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PFIZER INC - Quarter Report: 2022 July (Form 10-Q)


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended July 3, 2022

OR

TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______ to _______


COMMISSION FILE NUMBER 1-3619

----

PFIZER INC.
(Exact name of registrant as specified in its charter)
Delaware13-5315170
(State of Incorporation)(I.R.S. Employer Identification No.)

235 East 42nd Street, New York, New York  10017
(Address of principal executive offices)  (zip code)
(212) 733-2323
(Registrant’s telephone number)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $.05 par valuePFENew York Stock Exchange
1.000% Notes due 2027PFE27New York Stock Exchange
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YesxNo

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
YesxNo

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large Accelerated filer x              Accelerated filer                 Non-accelerated filer            Smaller reporting company      Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YesNo
x

At August 5, 2022, 5,612,351,809 shares of the issuer’s voting common stock were outstanding.



TABLE OF CONTENTS
Page
 
 
Item 2.
 
 
 
 
 
 
Item 3. 
Defaults Upon Senior SecuritiesN/A
Item 4. 
Mine Safety DisclosuresN/A
Item 5. 
Other InformationN/A
 
N/A = Not Applicable
2


DEFINED TERMS

Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this Form 10-Q (defined below) refer to Pfizer Inc. and its subsidiaries. Pfizer’s fiscal quarter-end for subsidiaries operating outside the U.S. is as of and for the three and six months ended May 29, 2022 and May 30, 2021, and for U.S. subsidiaries is as of and for the three and six months ended July 3, 2022 and July 4, 2021. References to “Notes” in this Form 10-Q are to the Notes to the Condensed or Consolidated Financial Statements in this Form 10-Q or in our 2021 Form 10-K. We also have used several other terms in this Form 10-Q, most of which are explained or defined below:
2021 Form 10-KAnnual Report on Form 10-K for the fiscal year ended December 31, 2021
ACIPAdvisory Committee on Immunization Practices
ALKanaplastic lymphoma kinase
Alliance revenuesRevenues from alliance agreements under which we co-promote products discovered or developed by other companies or us
ArenaArena Pharmaceuticals, Inc.
AstellasAstellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc.
ATTR-CMtransthyretin amyloid cardiomyopathy
BiohavenBiohaven Pharmaceutical Holding Company Ltd.
BioNTechBioNTech SE
BiopharmaPfizer Biopharmaceuticals Group
BLABiologics License Application
BMSBristol-Myers Squibb Company
BNT162b2*Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty
BODBoard of Directors
CDCU.S. Centers for Disease Control and Prevention
CGRPcalcitonin gene-related peptide
CMA
conditional marketing authorisation
Comirnaty*Pfizer-BioNTech COVID-19 Vaccine, also known as BNT162b2
Consumer Healthcare JVGSK Consumer Healthcare JV
COVID-19novel coronavirus disease of 2019
Developed Europe
Includes the following markets: Western Europe, Scandinavian countries and Finland
Developed MarketsIncludes the following markets: U.S., Developed Europe, Japan, South Korea, Australia, Canada and New Zealand
Developed Rest of World
Includes the following markets: Japan, South Korea, Australia, Canada and New Zealand
ECEuropean Commission
EMAEuropean Medicines Agency
Emerging Markets
Includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Central Europe, Eastern Europe, the Middle East, Africa and Turkey
EPSearnings per share
EUEuropean Union
EUAemergency use authorization
Exchange ActSecurities Exchange Act of 1934, as amended
FDAU.S. Food and Drug Administration
FFDCAU.S. Federal Food, Drug and Cosmetic Act
Form 10-QThis Quarterly Report on Form 10-Q for the quarterly period ended July 3, 2022
GAAPGenerally Accepted Accounting Principles
GISTgastrointestinal stromal tumors
GPDGlobal Product Development organization
GSKGlaxoSmithKline plc
HaleonHaleon plc
HIPAAHealth Insurance Portability and Accountability Act of 1996
HospiraHospira, Inc.
IPR&Din-process research and development
IRSU.S. Internal Revenue Service
JAKJanus kinase
JVjoint venture
KingKing Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.)
LIBORLondon Interbank Offered Rate
LOEloss of exclusivity
mCRCmetastatic colorectal cancer
mCRPC
metastatic castration-resistant prostate cancer
mCSPC
metastatic castration-sensitive prostate cancer
MD&AManagement’s Discussion and Analysis of Financial Condition and Results of Operations
3


MeridianMeridian Medical Technologies, Inc.
mRNAmessenger ribonucleic acid
MSAManufacturing Supply Agreement
MylanMylan N.V.
MyovantMyovant Sciences Ltd.
NDANew Drug Application
nmCRPC
non-metastatic castration-resistant prostate cancer
NSCLCnon-small cell lung cancer
OPKOOPKO Health, Inc.
OTCover-the-counter
Paxlovid*an oral COVID-19 treatment (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
PC1Pfizer CentreOne
PGSPfizer Global Supply
PharmaciaPharmacia Corporation
PRACPharmacovigilance Risk Assessment Committee
PsApsoriatic arthritis
QTDQuarter-to-date or three months ended
RArheumatoid arthritis
RCCrenal cell carcinoma
R&Dresearch and development
ReViralReViral Ltd.
SandozSandoz, Inc., a division of Novartis AG
SECU.S. Securities and Exchange Commission
sNDAsupplemental new drug application
TSAstransition service arrangements
UCulcerative colitis
U.K.United Kingdom
U.S.United States
Upjohn BusinessPfizer’s former global, primarily off-patent branded and generics business, which included a portfolio of 20 globally recognized solid oral dose brands, including Lipitor, Lyrica, Norvasc, Celebrex and Viagra, as well as a U.S.-based generics platform, Greenstone, that was spun-off on November 16, 2020 and combined with Mylan to create Viatris
ViatrisViatris Inc.
ViiVViiV Healthcare Limited
WRDMWorldwide Research, Development and Medical
YTD
Year-to-date or six months ended
*This Form 10-Q includes discussion of the COVID-19 vaccine that Pfizer has co-developed with BioNTech (BNT162b2) and our oral COVID-19 treatment (Paxlovid). The vaccine may be referred to by its brand name, Comirnaty (approved under a BLA in the U.S.), or as BNT162b2 (authorized under EUA in the U.S.). The vaccine is FDA-approved to prevent COVID-19 in individuals 12 years of age and older. In addition, Comirnaty/BNT162b2 is authorized for emergency use by the FDA for individuals 6 months of age and older, as a third dose for certain immunocompromised individuals 5 years of age and older, as a booster dose for individuals 5 years of age and older and as a second booster dose for individuals 50 years of age and older and for certain immunocompromised individuals 12 years of age and older. Paxlovid is authorized for emergency use by the FDA under an EUA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FFDCA unless the declaration is terminated or authorization revoked sooner. The FDA has issued EUAs to certain other companies for products intended for the prevention or treatment of COVID-19 and may continue to do so during the duration of the Declaration. See the EUA Fact Sheets at www.cvdvaccine-us.com and www.covid19oralrx.com.
This Form 10-Q includes discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.
Some amounts in this Form 10-Q may not add due to rounding. All percentages have been calculated using unrounded amounts. All trademarks mentioned are the property of their owners.
The information contained on our website, our Facebook, Instagram, YouTube and LinkedIn pages or our Twitter accounts, or any third-party website, is not incorporated by reference into this Form 10-Q.
4


PART I.  FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
 Three Months EndedSix Months Ended
(MILLIONS, EXCEPT PER COMMON SHARE DATA)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Revenues$27,742 $18,899 $53,402 $33,415 
Costs and expenses:
Cost of sales(a)
8,648 6,996 18,632 11,153 
Selling, informational and administrative expenses(a)
3,048 2,923 5,642 5,700 
Research and development expenses(a)
2,815 2,239 5,116 4,233 
Acquired in-process research and development expenses(b)
219 356 238 
Amortization of intangible assets822 917 1,657 1,776 
Restructuring charges and certain acquisition-related costs189 (1)381 21 
Other (income)/deductions––net772 (1,343)1,122 (2,347)
Income from continuing operations before provision/(benefit) for taxes on income11,447 6,949 20,497 12,641 
Provision/(benefit) for taxes on income1,570 1,123 2,742 1,931 
Income from continuing operations9,877 5,825 17,756 10,710 
Discontinued operations––net of tax34 (236)26 (235)
Net income before allocation to noncontrolling interests9,911 5,589 17,781 10,475 
Less: Net income attributable to noncontrolling interests26 12 35 
Net income attributable to Pfizer Inc. common shareholders$9,906 $5,563 $17,769 $10,440 
Earnings per common share––basic:
    
Income from continuing operations attributable to Pfizer Inc. common shareholders$1.76 $1.04 $3.17 $1.91 
Discontinued operations––net of tax0.01 (0.04)— (0.04)
Net income attributable to Pfizer Inc. common shareholders$1.77 $0.99 $3.17 $1.87 
Earnings per common share––diluted:
    
Income from continuing operations attributable to Pfizer Inc. common shareholders$1.73 $1.02 $3.09 $1.88 
Discontinued operations––net of tax0.01 (0.04)— (0.04)
Net income attributable to Pfizer Inc. common shareholders$1.73 $0.98 $3.10 $1.84 
Weighted-average shares––basic5,593 5,598 5,605 5,591 
Weighted-average shares––diluted5,712 5,678 5,735 5,670 
(a)Exclusive of amortization of intangible assets.
(b)See Note 1D.
See Accompanying Notes.
5


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(UNAUDITED)
 Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Net income before allocation to noncontrolling interests$9,911 $5,589 $17,781 $10,475 
Foreign currency translation adjustments, net(1,268)36 (1,631)501 
Unrealized holding gains/(losses) on derivative financial instruments, net651 (248)854 (35)
Reclassification adjustments for (gains)/losses included in net income(a)
(144)(21)(357)238 
 507 (270)497 203 
Unrealized holding gains/(losses) on available-for-sale securities, net(486)59 (620)138 
Reclassification adjustments for (gains)/losses included in net income(b)
255 61 487 (181)
 (232)120 (132)(43)
Reclassification adjustments related to amortization of prior service costs and other, net(31)(39)(68)(79)
Reclassification adjustments related to curtailments of prior service costs and other, net(1)(10)(5)
 (30)(41)(78)(84)
Other comprehensive income/(loss), before tax(1,023)(155)(1,344)577 
Tax provision/(benefit) on other comprehensive income/(loss)(55)(63)(115)21 
Other comprehensive income/(loss) before allocation to noncontrolling interests$(968)$(92)$(1,228)$556 
Comprehensive income/(loss) before allocation to noncontrolling interests$8,943 $5,498 $16,553 $11,031 
Less: Comprehensive income/(loss) attributable to noncontrolling interests— 28 38 
Comprehensive income/(loss) attributable to Pfizer Inc.$8,943 $5,469 $16,546 $10,992 
(a)Reclassified into Other (income)/deductions—net and Cost of sales. See Note 7E.
(b)Reclassified into Other (income)/deductions—net.
See Accompanying Notes.
6


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(MILLIONS)July 3,
2022
December 31, 2021
(Unaudited)
Assets
Cash and cash equivalents$1,780 $1,944 
Short-term investments31,524 29,125 
Trade accounts receivable, less allowance for doubtful accounts: 2022—$461; 2021—$492
15,155 11,479 
Inventories10,454 9,059 
Current tax assets2,583 4,266 
Other current assets5,970 3,820 
Total current assets67,466 59,693 
Equity-method investments14,799 16,472 
Long-term investments4,163 5,054 
Property, plant and equipment, less accumulated depreciation: 2022—$14,969; 2021—$15,074
15,244 14,882 
Identifiable intangible assets29,065 25,146 
Goodwill49,891 49,208 
Noncurrent deferred tax assets and other noncurrent tax assets7,002 3,341 
Other noncurrent assets7,659 7,679 
Total assets$195,290 $181,476 
Liabilities and Equity  
Short-term borrowings, including current portion of long-term debt: 2022—$1,276; 2021—$1,636
$5,990 $2,241 
Trade accounts payable6,208 5,578 
Dividends payable2,245 2,249 
Income taxes payable3,350 1,266 
Accrued compensation and related items1,997 3,332 
Deferred revenues3,804 3,067 
Other current liabilities23,816 24,939 
Total current liabilities47,410 42,671 
Long-term debt34,294 36,195 
Pension benefit obligations3,030 3,489 
Postretirement benefit obligations227 235 
Noncurrent deferred tax liabilities558 349 
Other taxes payable10,990 11,331 
Other noncurrent liabilities11,311 9,743 
Total liabilities107,821 104,013 
Commitments and Contingencies
Common stock476 473 
Additional paid-in capital91,183 90,591 
Treasury stock(113,939)(111,361)
Retained earnings116,608 103,394 
Accumulated other comprehensive loss(7,119)(5,897)
Total Pfizer Inc. shareholders’ equity87,208 77,201 
Equity attributable to noncontrolling interests261 262 
Total equity87,469 77,462 
Total liabilities and equity$195,290 $181,476 
See Accompanying Notes.
7


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF EQUITY
(UNAUDITED)
PFIZER INC. SHAREHOLDERS
Common StockTreasury Stock
(MILLIONS, EXCEPT PER COMMON SHARE DATA)SharesPar ValueAdd’l
Paid-In Capital
SharesCostRetained EarningsAccum. Other Comp.
Loss
Share-
holders’ Equity
Non-controlling interestsTotal Equity
Balance, April 3, 2022
9,494 $476 $90,844 (3,903)$(113,931)$111,193 $(6,157)$82,424 $261 $82,685 
Net income9,906 9,906 9,911 
Other comprehensive income/(loss), net of tax
(963)(963)(5)(968)
Cash dividends declared, per share: $0.80
Common stock(4,489)(4,489)(4,489)
Share-based payment transactions— 339 — (8)(2)330 330 
Purchases of common stock— — — — 
Other— — — — — — — 
Balance, July 3, 2022
9,496 $476 $91,183 (3,903)$(113,939)$116,608 $(7,119)$87,208 $261 $87,469 
PFIZER INC. SHAREHOLDERS
Common StockTreasury Stock
(MILLIONS, EXCEPT PER COMMON SHARE DATA)SharesPar ValueAdd’l
Paid-In Capital
SharesCostRetained EarningsAccum. Other Comp.
Loss
Share-
holders’ Equity
Non-controlling interestsTotal Equity
Balance, April 4, 2021
9,445 $472 $89,002 (3,851)$(111,349)$95,158 $(4,664)$68,620 $245 $68,865 
Net income5,563 5,563 26 5,589 
Other comprehensive income/(loss), net of tax(94)(94)(92)
Cash dividends declared, per share: $0.78
Common stock (4,293)(4,293)(4,293)
Share-based payment transactions— 334 — (7)(76)251 251 
Purchases of common stock— — — — 
Other— — — (7)(6)— (6)
Balance, July 4, 2021
9,450 $472 $89,336 (3,851)$(111,356)$96,346 $(4,758)$70,042 $273 $70,315 
PFIZER INC. SHAREHOLDERS
Common StockTreasury Stock
(MILLIONS, EXCEPT PER COMMON SHARE DATA)SharesPar ValueAdd’l
Paid-In Capital
SharesCostRetained EarningsAccum. Other Comp.
Loss
Share-
holders’ Equity
Non-controlling interestsTotal Equity
Balance, January 1, 2022
9,471 $473 $90,591 (3,851)$(111,361)$103,394 $(5,897)$77,201 $262 $77,462 
Net income17,769 17,769 12 17,781 
Other comprehensive income/(loss), net of tax(1,223)(1,223)(6)(1,228)
Cash dividends declared, per share: $0.80
Common stock(4,489)(4,489)(4,489)
Share-based payment transactions25 588 (12)(578)(66)(53)(53)
Purchases of common stock(39)(2,000)(2,000)(2,000)
Other— — — (7)(4)
Balance, July 3, 2022
9,496 $476 $91,183 (3,903)$(113,939)$116,608 $(7,119)$87,208 $261 $87,469 
PFIZER INC. SHAREHOLDERS
Common StockTreasury Stock
(MILLIONS, EXCEPT PER COMMON SHARE DATA)SharesPar ValueAdd’l
Paid-In Capital
SharesCostRetained EarningsAccum. Other Comp.
Loss
Share-
holders’ Equity
Non-controlling interestsTotal Equity
Balance, January 1, 2021
9,407 $470 $88,674 (3,840)$(110,988)$90,392 $(5,310)$63,238 $235 $63,473 
Net income10,440 10,440 35 10,475 
Other comprehensive income/(loss), net of tax552 552 556 
Cash dividends declared, per share: $0.78
Common stock (4,377)(4,377)(4,377)
Share-based payment transactions43 662 (11)(368)(76)221 221 
Purchases of common stock— — — — 
Other— — — (33)(33)— (33)
Balance, July 4, 2021
9,450 $472 $89,336 (3,851)$(111,356)$96,346 $(4,758)$70,042 $273 $70,315 
See Accompanying Notes.
8


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
 Six Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
Operating Activities  
Net income before allocation to noncontrolling interests$17,781 $10,475 
Discontinued operations—net of tax26 (235)
Net income from continuing operations before allocation to noncontrolling interests17,756 10,710 
Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities:  
Depreciation and amortization2,362 2,515 
Asset write-offs and impairments58 55 
Deferred taxes from continuing operations(3,461)137 
Share-based compensation expense373 393 
Benefit plan contributions in excess of expense/income(146)(779)
Other adjustments, net1,270 (1,305)
Other changes in assets and liabilities, net of acquisitions and divestitures(3,496)4,102 
Net cash provided by operating activities from continuing operations14,717 15,828 
Net cash provided by/(used in) operating activities from discontinued operations(5)
Net cash provided by operating activities14,711 15,837 
Investing Activities  
Purchases of property, plant and equipment(1,394)(1,091)
Purchases of short-term investments(18,937)(15,982)
Proceeds from redemptions/sales of short-term investments20,151 7,572 
Net (purchases of)/proceeds from redemptions/sales of short-term investments with original maturities of three months or less(3,153)(505)
Purchases of long-term investments(1,324)(100)
Proceeds from redemptions/sales of long-term investments226 297 
Acquisition of business, net of cash acquired(6,225)— 
Other investing activities, net(91)(72)
Net cash provided by/(used in) investing activities from continuing operations(10,746)(9,880)
Net cash provided by/(used in) investing activities from discontinued operations— (3)
Net cash provided by/(used in) investing activities(10,746)(9,884)
Financing Activities  
Proceeds from short-term borrowings4,012 — 
Net (payments on)/proceeds from short-term borrowings with original maturities of three months or less
379 (499)
Principal payments on long-term debt(1,609)— 
Purchases of common stock(2,000)— 
Cash dividends paid(4,493)(4,355)
Other financing activities, net(347)(509)
Net cash provided by/(used in) financing activities(4,058)(5,364)
Effect of exchange-rate changes on cash and cash equivalents and restricted cash and cash equivalents
(67)
Net increase/(decrease) in cash and cash equivalents and restricted cash and cash equivalents(159)593 
Cash and cash equivalents and restricted cash and cash equivalents, at beginning of period1,983 1,825 
Cash and cash equivalents and restricted cash and cash equivalents, at end of period$1,824 $2,418 
Supplemental Cash Flow Information
Cash paid/(received) during the period for:  
Income taxes
$3,098 $2,188 
Interest paid
771 798 
Interest rate hedges(10)(67)
Non-cash transaction:
Right-of-use assets obtained in exchange for lease liabilities$242 $1,204 
See Accompanying Notes.
9


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Note 1. Basis of Presentation and Significant Accounting Policies

A. Basis of Presentation

We prepared these condensed consolidated financial statements in conformity with U.S. GAAP, consistent in all material respects with those applied in our 2021 Form 10-K. As permitted under the SEC requirements for interim reporting, certain footnotes or other financial information have been condensed or omitted.

These financial statements include all normal and recurring adjustments that are considered necessary for the fair statement of results for the interim periods presented. The information included in this Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2021 Form 10-K. Revenues, expenses, assets and liabilities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year.

Pfizer’s fiscal quarter-end for subsidiaries operating outside the U.S. is as of and for the three and six months ended May 29, 2022 and May 30, 2021, and for U.S. subsidiaries is as of and for the three and six months ended July 3, 2022 and July 4, 2021.
At the beginning of our fiscal fourth quarter of 2021, we reorganized our commercial operations and began to manage our commercial operations through a new global structure consisting of two operating segments, each led by a single manager: Biopharma, our innovative science-based biopharmaceutical business, and PC1, our global contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients. Biopharma is the only reportable segment. See Note 17A in our 2021 Form 10-K and Note 13 below.
Business development activities completed in 2021 and 2022 impacted financial results in the periods presented. Discontinued operations in the periods presented relate to the previously divested Meridian subsidiary and post-closing adjustments for other previously divested businesses. See Notes 1A and 2B in our 2021 Form 10-K, and Note 2B below.
We have made certain reclassification adjustments to conform prior-period amounts to the current presentation for discontinued operations, acquired IPR&D expenses and segment reporting.
B. New Accounting Standard Adopted in 2022
On January 1, 2022, we early adopted a new accounting standard for contract assets and contract liabilities acquired in a business combination. Under the new standard, acquired contract assets and contract liabilities are required to be recognized and measured by the acquirer on the acquisition date in accordance with Accounting Standards Codification 606. This new guidance generally results in the acquirer recognizing contract assets and contract liabilities at the same amounts that were recorded by the acquiree. Previously, these amounts were recognized by the acquirer at fair value as of the acquisition date. We adopted this new standard on a prospective basis and there was no impact to our consolidated financial statements.
C. Revenues and Trade Accounts Receivable
Revenue Recognition––We record revenues from product sales when there is a transfer of control of the product from us to the customer. We typically determine transfer of control based on when the product is shipped or delivered and title passes to the customer. For certain contracts, the finished product may temporarily be stored at our or our third-party subcontractors’ locations under a bill-and-hold arrangement. Revenue is recognized on bill-and-hold arrangements at the point in time when the customer obtains control of the product and all of the following criteria have been met: the arrangement is substantive; the product is identified separately as belonging to the customer; the product is ready for physical transfer to the customer; and we do not have the ability to use the product or direct it to another customer. In determining when the customer obtains control of the product, we consider certain indicators, including whether we have a present right to payment from the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received.
Customers––Our prescription pharmaceutical products, with the exception of Paxlovid, are sold principally to wholesalers, but we also sell directly to retailers, hospitals, clinics, government agencies and pharmacies. We principally sell Paxlovid to government agencies. In the U.S., we primarily sell our vaccine products directly to the federal government, CDC, wholesalers, individual provider offices, retail pharmacies and integrated delivery networks. Outside the U.S., we primarily sell our vaccines to government and non-government institutions.
10


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Deductions from Revenues––Our accruals for Medicare, Medicaid and related state program and performance-based contract rebates, chargebacks, sales allowances and sales returns and cash discounts are as follows:
(MILLIONS)July 3,
2022
December 31, 2021
Reserve against Trade accounts receivable, less allowance for doubtful accounts
$1,057 $1,077 
Other current liabilities:
Accrued rebates3,875 3,811 
Other accruals458 528 
Other noncurrent liabilities
386 433 
Total accrued rebates and other sales-related accruals$5,776 $5,850 
Trade Accounts Receivable––Trade accounts receivable are stated at their net realizable value. The allowance for credit losses reflects our best estimate of expected credit losses of the receivables portfolio determined on the basis of historical experience, current information, and forecasts of future economic conditions. In developing the estimate for expected credit losses, trade accounts receivables are segmented into pools of assets depending on market (U.S. versus international), delinquency status, and customer type (high risk versus low risk and government versus non-government), and fixed reserve percentages are established for each pool of trade accounts receivables.
In determining the reserve percentages for each pool of trade accounts receivables, we considered our historical experience with certain customers and customer types, regulatory and legal environments, country and political risk, and other relevant current and future forecasted macroeconomic factors. These credit risk indicators are monitored on a quarterly basis to determine whether there have been any changes in the economic environment that would indicate the established reserve percentages should be adjusted, and are considered on a regional basis to reflect more geographic-specific metrics. Additionally, write-offs and recoveries of customer receivables are tracked against collections on a quarterly basis to determine whether the reserve percentages remain appropriate. When management becomes aware of certain customer-specific factors that impact credit risk, specific allowances for these known troubled accounts are recorded. Trade accounts receivable are written off after all reasonable means to collect the full amount (including litigation, where appropriate) have been exhausted.
During the three and six months ended July 3, 2022 and July 4, 2021, additions to the allowance for credit losses, write-offs and recoveries of customer receivables were not material to our condensed consolidated financial statements. For additional information on our trade accounts receivable, see Note 1H in our 2021 Form 10-K.

D. Acquired In-Process Research and Development Expenses

In the first quarter of 2022, we began reporting acquired IPR&D expense as a separate line item in our consolidated statements of income. Acquired in-process research and development expenses includes costs incurred in connection with (a) all upfront and milestone payments on collaboration and in-license agreements, including premiums on equity securities and (b) asset acquisitions of acquired IPR&D. These costs were previously recorded in Research and development expenses. Prior periods have been revised to conform to the current period presentation. When we acquire net assets that do not constitute a business, as defined in U.S. GAAP, no goodwill is recognized and acquired IPR&D is expensed. The fair value of IPR&D acquired in connection with a business combination is recorded on the balance sheet as Identifiable intangible assets. See Notes 1E and 10 in our 2021 Form 10-K.
Note 2. Acquisition, Discontinued Operations, Equity-Method Investment and Collaborative Arrangement
A. Acquisition
Arena––On March 11, 2022, we acquired Arena, a clinical stage company, for $100 per share in cash. The total fair value of the consideration transferred was $6.6 billion ($6.2 billion, net of cash acquired). In addition, $138 million in payments to Arena employees for the fair value of previously unvested long-term incentive awards was recognized as post-closing compensation expense and recorded in Restructuring charges and certain acquisition-related costs (see Note 3).
Arena’s portfolio includes development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including UC, Crohn’s disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata. In connection with this acquisition, we provisionally recorded: (i) $5.5 billion in Identifiable intangible assets, consisting of $5.0 billion of IPR&D and $460 million of indefinite-lived Licensing agreements and other, (ii) $1.0 billion of Goodwill and (iii) $510 million of net deferred tax liabilities. The allocation of the consideration transferred to the assets acquired and the liabilities assumed has not yet been finalized.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
B. Discontinued Operations
Meridian––On December 31, 2021, we completed the sale of our Meridian subsidiary. In the three and six months ended July 3, 2022, the amounts recorded under the interim TSAs and MSA were not material.
Upjohn Separation and Combination with Mylan––On November 16, 2020, we completed the spin-off and the combination of the Upjohn Business with Mylan to form Viatris. In connection with this transaction, Pfizer and Viatris entered into various agreements to effect the separation and combination and to provide a framework for our relationship after the combination, including a separation and distribution agreement, interim operating models, including agency arrangements, MSAs, TSAs, a tax matters agreement, and an employee matters agreement, among others. The amounts recorded under these agreements were not material to our consolidated results of operations in the three and six months ended July 3, 2022 and July 4, 2021. Net amounts due from Viatris under the agreements were approximately $272 million as of July 3, 2022 and $53 million as of December 31, 2021. The cash flows associated with the agreements are included in Net cash provided by operating activities from continuing operations, except for a $277 million payment to Viatris made in the first quarter of 2021 pursuant to terms of the separation agreement, which is reported in Other financing activities, net.
Discontinued operations—net of tax for the three and six months ended July 4, 2021 reflects pre-tax loss from discontinued operations of $346 million and $337 million, respectively, and primarily includes pre-disposal operations related to our former Meridian subsidiary including a $345 million pre-tax expense to resolve a Multi-District Litigation relating to EpiPen against the Company in the U.S. District Court for the District of Kansas (prior to presenting Meridian as discontinued operations, this EpiPen litigation amount was included in Other (income)/deductions––net). For the three and six months ended July 3, 2022, Discontinued operations—net of tax reflects pre-tax income from discontinued operations of $34 million and $24 million, respectively, and relates to post-closing adjustments for previously divested businesses primarily for tax and legal matters.
C. Equity-Method Investment
Consumer Healthcare JV––On July 31, 2019, we completed a transaction in which we and GSK combined our respective consumer healthcare businesses into a new JV that operated globally under the GSK Consumer Healthcare name. In exchange for the contribution of our consumer healthcare business to the JV, we received a 32% equity stake in the new company and GSK owned the remaining 68%. We have accounted for our interest in the Consumer Healthcare JV as an equity-method investment. The carrying value of our investment in the Consumer Healthcare JV is $14.6 billion as of July 3, 2022 and $16.3 billion as of December 31, 2021 and is reported as a private equity investment in Equity-method investments as of July 3, 2022 and December 31, 2021. The Consumer Healthcare JV is a foreign investee whose reporting currency is the U.K. pound, and therefore we translate its financial statements into U.S. dollars and recognize the impact of foreign currency translation adjustments in the carrying value of our investment and in other comprehensive income. The decrease in the value of our investment from December 31, 2021 is primarily due to $1.7 billion in pre-tax foreign currency translation adjustments (see Note 6), as well as dividends totaling approximately $354 million, partially offset by our share of the JV’s earnings. We record our share of earnings from the Consumer Healthcare JV on a quarterly basis on a one-quarter lag in Other (income)/deductions––net. Our total share of the JV’s earnings generated in the first quarter of 2022, which we recorded in our operating results in the second quarter of 2022, was $150 million. Our total share of the JV’s earnings generated in the fourth quarter of 2021 and first quarter of 2022, which we recorded in our operating results in the first six months of 2022, was $335 million. Our total share of the JV’s earnings generated in the first quarter of 2021, which we recorded in our operating results in the second quarter of 2021, was $148 million. Our total share of the JV’s earnings generated in the fourth quarter of 2020 and first quarter of 2021, which we recorded in our operating results in the first six months of 2021, was $218 million. The total amortization and adjustment of basis differences resulting from the excess of the initial fair value of our investment over the underlying equity in the carrying value of the net assets of the JV is included in Other (income)/deductions––net and was not material to our results of operations in the periods presented. See Note 4.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Summarized financial information for our equity method investee, the Consumer Healthcare JV, for the three and six months ending March 31, 2022, the most recent period available, and for the three and six months ending March 31, 2021, is as follows:
Three Months EndedSix Months Ended
(MILLIONS)March 31,
2022
March 31,
2021
March 31,
2022
March 31,
2021
Net sales$3,526 $3,180 $6,945 $6,275 
Cost of sales(1,322)(1,169)(2,634)(2,356)
Gross profit$2,204 $2,011 $4,312 $3,919 
Income from continuing operations487 483 1,077 716 
Net income487 483 1,077 716 
Income attributable to shareholders468 461 1,046 682 

In connection with GSK’s previously announced planned demerger of at least 80% of GSK’s 68% equity interest in the Consumer Healthcare JV, in March 2022 the Consumer Healthcare JV completed its offering of a total aggregate principal amount of $8.75 billion in U.S. dollar-denominated senior notes of various maturities, €2.35 billion in euro-denominated senior notes of various maturities and £700 million in U.K. pound-denominated senior notes of various maturities (collectively, the “notes”). The notes were guaranteed by GSK generally up to and excluding the date of the demerger (the “Guarantee Assumption Date”). We agreed to indemnify GSK for 32% (representing our pro rata equity interest in the Consumer Healthcare JV) of any amount payable by GSK pursuant to its guarantee of the notes. Our indemnity was provided solely for the benefit of GSK. Neither we nor any of our subsidiaries is an issuer or guarantor of any of the notes.
Following its issuance of the notes in March 2022, which fell in our international second quarter of 2022, the Consumer Healthcare JV loaned to us and GSK the net proceeds received from the notes on a pro rata equity ownership basis, for which we received a loan of £2.9 billion ($3.7 billion as of the end of our second quarter of 2022), at an interest rate of 1.365% per annum payable semi-annually in arrears.
On July 18, 2022, GSK completed its demerger of the Consumer Healthcare JV which became Haleon, an independent, publicly traded company listed on the London Stock Exchange that holds the joint Consumer Healthcare business of GSK and Pfizer following the demerger. In conjunction with the demerger, we received £3.5 billion ($4.2 billion) in dividends from the JV in July 2022, which decreased the carrying value of our investment. Simultaneous with the receipt of the dividends, we repaid the loan from the JV. GSK similarly received pro rata dividends and simultaneously repaid its pro rata loan from the JV. In conjunction with these transactions, our indemnification of GSK’s guarantee discussed above was terminated. We continue to own 32% of Haleon after the transactions related to the demerger and continue to account for our interest in Haleon as an equity-method investment.
D. Collaborative Arrangement
Collaboration with Biohaven––In November 2021, we entered into a collaboration and license agreement and related sublicense agreement with Biohaven and certain of its subsidiaries to commercialize rimegepant and zavegepant for the treatment and prevention of migraines outside of the U.S., subject to regulatory approval. Biohaven will continue to lead R&D globally and we have the exclusive right to commercialization globally, outside of the U.S. Upon the closing of the transaction on January 4, 2022, we paid Biohaven $500 million, including an upfront payment of $150 million and an equity investment of $350 million. We recognized $263 million for the upfront payment and premium paid on our equity investment in Acquired in-process research and development expenses. Biohaven is also eligible to receive up to $740 million in non-U.S. commercialization milestone payments, in addition to tiered double-digit royalties on net sales outside of the U.S. In addition to the milestone payments and royalties above, we will also reimburse Biohaven for the portion of certain additional milestone payments and royalties due to third parties in accordance with preexisting Biohaven agreements, which are attributed to ex-U.S. sales.
Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
A. Transforming to a More Focused Company Program
With the formation of the Consumer Healthcare JV in 2019 and the spin-off of our Upjohn Business in the fourth quarter of 2020, Pfizer has transformed into a focused, global leader in science-based innovative medicines and vaccines. We continue our efforts to ensure our cost base and support model align appropriately with this operating structure. While certain direct costs
13


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
transferred to the Consumer Healthcare JV, and to the Upjohn Business in connection with the spin-off, there are indirect costs which did not transfer. This program is primarily composed of the following three initiatives:
We are taking steps to restructure our corporate enabling functions to appropriately support our business, R&D and PGS platform functions. We expect costs, primarily related to restructuring our corporate enabling functions, to total $1.8 billion, with substantially all costs to be cash expenditures. Actions include, among others, changes in location of certain activities, expanded use and co-location of centers of excellence and shared services, and increased use of digital technologies. The associated actions and the specific costs primarily include severance and benefit plan impacts, exit costs as well as associated implementation costs.
In addition, we are transforming our commercial go-to market model in the way we engage patients and physicians. We expect costs of $1.2 billion, with all costs to be cash expenditures. Actions include, among others, centralization of certain activities and enhanced use of digital technologies. The costs for this effort primarily include severance and associated implementation costs.
We are also optimizing our manufacturing network under this program and incurring one-time costs for cost-reduction initiatives related to our manufacturing operations. We expect to incur costs of $800 million, with approximately 25% of the costs to be non-cash. The costs for this effort include, among other things, severance costs, implementation costs, product transfer costs, site exit costs, as well as accelerated depreciation.
The program costs discussed above are expected to be incurred primarily from 2020 through 2022, and may be rounded and represent approximations.
From the start of this program in the fourth quarter of 2019 through July 3, 2022, we incurred costs of $2.5 billion, of which $987 million ($800 million of restructuring charges) is associated with Biopharma.
B. Key Activities
The following summarizes acquisitions and cost-reduction/productivity initiatives costs and credits:
Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Restructuring charges/(credits):    
Employee terminations$110 $(4)$135 $19 
Asset impairments20 28 (3)
Exit costs/(credits)18 (3)29 (3)
Restructuring charges/(credits)(a)
147 (5)191 12 
Transaction costs(b)
36 — 42 — 
Integration costs and other(c)
148 
Restructuring charges and certain acquisition-related costs189 (1)381 21 
Net periodic benefit costs/(credits) recorded in Other (income)/deductions––net
— (6)12 
Additional depreciation––asset restructuring recorded in our condensed consolidated statements of income as follows(d):
    
Cost of sales27 15 34 
Selling, informational and administrative expenses— 16 — 16 
Total additional depreciation––asset restructuring43 15 49 
Implementation costs recorded in our condensed consolidated statements of income as follows(e):
    
Cost of sales15 10 27 21 
Selling, informational and administrative expenses134 80 208 144 
Total implementation costs149 90 235 166 
Total costs associated with acquisitions and cost-reduction/productivity initiatives$345 $137 $625 $248 
(a)Primarily represents cost reduction initiatives. Restructuring charges/(credits) associated with Biopharma: charges of $50 million and $46 million for the three and six months ended July 3, 2022, respectively, and credits of $4 million and charges of $1 million for the three and six months ended July 4, 2021, respectively.
(b)Represents external costs for banking, legal, accounting and other similar services.
14


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(c)Represents external, incremental costs directly related to integrating acquired businesses, such as expenditures for consulting and the integration of systems and processes, and certain other qualifying costs. In the three and six months ended July 3, 2022, integration costs and other were mostly related to our acquisition of Arena, including $138 million in payments to Arena employees in the first quarter of 2022 for the fair value of previously unvested long-term incentive awards. See Note 2A.
(d)Represents the impact of changes in the estimated useful lives of assets involved in restructuring actions.
(e)Represents external, incremental costs directly related to implementing our non-acquisition-related cost-reduction/productivity initiatives.
The following summarizes the components and changes in restructuring accruals:
(MILLIONS)Employee
Termination
Costs
Asset
Impairment
Charges
Exit CostsAccrual
Balance, December 31, 2021(a)
$1,014 $— $57 $1,071 
Provision135 28 29 191 
Utilization and other(b)
(244)(28)(78)(349)
Balance, July 3, 2022(c)
$904 $— $$913 
(a)Included in Other current liabilities ($816 million) and Other noncurrent liabilities ($255 million).
(b)Includes adjustments for foreign currency translation.
(c)Included in Other current liabilities ($794 million) and Other noncurrent liabilities ($119 million).
Note 4. Other (Income)/Deductions—Net
Components of Other (income)/deductions––net include:
 Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Interest income$(30)$(13)$(44)$(12)
Interest expense293 316 614 651 
Net interest expense263 303 571 639 
Royalty-related income(217)(212)(389)(388)
Net (gains)/losses on asset disposals— (58)(1)(98)
Net (gains)/losses recognized during the period on equity securities(a)
541 (800)1,241 (1,200)
Income from collaborations, out-licensing arrangements and sales of compound/product rights(b)
(5)(21)(14)(252)
Net periodic benefit costs/(credits) other than service costs295 (237)12 (503)
Certain legal matters, net19 24 98 74 
Consumer Healthcare JV equity method (income)/loss(c)
(149)(140)(334)(202)
Other, net26 (201)(62)(417)
Other (income)/deductions––net$772 $(1,343)$1,122 $(2,347)
(a)The losses in the second quarter and first six months of 2022 include, among other things, unrealized losses of $432 million and $776 million, respectively, related to investments in BioNTech and Cerevel Therapeutics Holdings, Inc. (Cerevel). The gains in the second quarter and first six months of 2021 included, among other things, unrealized gains of $917 million and $1.0 billion, respectively, related to investments in BioNTech and Cerevel.
(b)The first six months of 2021 included, among other things, $188 million of net collaboration income from BioNTech in the first quarter of 2021 related to Comirnaty.
(c)See Note 2C.
Note 5. Tax Matters
A. Taxes on Income from Continuing Operations
Our effective tax rate for continuing operations was 13.7% for the second quarter of 2022, compared to 16.2% for the second quarter of 2021, and was 13.4% for the first six months of 2022, compared to 15.3% for the first six months of 2021. The lower effective tax rates for the second quarter and first six months of 2022, compared to the second quarter and first six months of 2021, were primarily due to the favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business.
We elected, with the filing of our 2018 U.S. Federal Consolidated Income Tax Return, to pay our initial estimated $15 billion repatriation tax liability on accumulated post-1986 foreign earnings over eight years through 2026. The fourth annual installment of this liability was paid by its April 18, 2022 due date. The fifth annual installment is due April 18, 2023 and is reported in current Income taxes payable as of July 3, 2022. The remaining liability is reported in noncurrent Other taxes
15


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
payable. Our obligations may vary as a result of changes in our uncertain tax positions and/or availability of attributes such as foreign tax and other credit carryforwards.
B. Tax Contingencies

We are subject to income tax in many jurisdictions, and a certain degree of estimation is required in recording the assets and liabilities related to income taxes. All of our tax positions are subject to audit by the local taxing authorities in each tax jurisdiction. These tax audits can involve complex issues, interpretations and judgments and the resolution of matters may span multiple years, particularly if subject to negotiation or litigation.

The U.S. is one of our major tax jurisdictions, and we are regularly audited by the IRS. With respect to Pfizer, the IRS has issued Revenue Agent’s Reports (RARs) for tax years 2011-2013 and 2014-2015. We are not in agreement with the RARs and are currently appealing certain disputed issues. Tax years 2016-2018 are currently under audit. Tax years 2019-2022 are open but not under audit. All other tax years are closed. In addition to the open audit years in the U.S., we have open audit years in certain major international tax jurisdictions dating back to 2011.
For additional information, see Note 5D in our 2021 Form 10-K.
C. Tax Provision/(Benefit) on Other Comprehensive Income/(Loss)
Components of Tax provision/(benefit) on other comprehensive income/(loss) include:
Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Foreign currency translation adjustments, net(a)
$(114)$(19)$(185)$
Unrealized holding gains/(losses) on derivative financial instruments, net98 (51)130 
Reclassification adjustments for (gains)/losses included in net income(3)(26)35 
95 (50)105 43 
Unrealized holding gains/(losses) on available-for-sale securities, net(61)(78)17 
Reclassification adjustments for (gains)/losses included in net income32 61 (23)
(29)15 (17)(5)
Reclassification adjustments related to amortization of prior service costs and other, net(7)(8)(16)(17)
Reclassification adjustments related to curtailments of prior service costs and other, net— (1)(2)(1)
(8)(8)(18)(18)
Tax provision/(benefit) on other comprehensive income/(loss)$(55)$(63)$(115)$21 
(a)Taxes are not provided for foreign currency translation adjustments relating to investments in international subsidiaries that we intend to hold indefinitely.
Note 6. Accumulated Other Comprehensive Loss, Excluding Noncontrolling Interests
The following summarizes the changes, net of tax, in Accumulated other comprehensive loss:
 Net Unrealized Gains/(Losses)Benefit Plans 
(MILLIONS)Foreign Currency Translation Adjustments Derivative Financial InstrumentsAvailable-For-Sale SecuritiesPrior Service (Costs)/Credits and OtherAccumulated Other Comprehensive Income/(Loss)
Balance, December 31, 2021
$(6,172)$119 $(220)$377 $(5,897)
Other comprehensive income/(loss)(a)
(1,440)392 (116)(59)(1,223)
Balance, July 3, 2022$(7,612)$511 $(336)$318 $(7,119)
(a)Amounts do not include foreign currency translation adjustments attributable to noncontrolling interests. Foreign currency translation adjustments include net losses related to our equity method investment in the Consumer Healthcare JV (see Note 2C) and the impact of our net investment hedging program.

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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 7. Financial Instruments
A. Fair Value Measurements

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis and Fair Value Hierarchy, using a Market Approach:
July 3, 2022December 31, 2021
(MILLIONS)TotalLevel 1Level 2TotalLevel 1Level 2
Financial assets:
Short-term investments
Equity securities with readily determinable fair values:
Money market funds$4,373 $— $4,373 $5,365 $— $5,365 
Available-for-sale debt securities:
Government and agency—non-U.S.
21,758 — 21,758 17,318 — 17,318 
Government and agency—U.S.
2,839 — 2,839 4,050 — 4,050 
Corporate and other
1,024 — 1,024 647 — 647 
25,621 — 25,621 22,014 — 22,014 
Total short-term investments29,994 — 29,994 27,379 — 27,379 
Other current assets
Derivative assets:
Interest rate contracts
— — 
Foreign exchange contracts
1,322 — 1,322 704 — 704 
Total other current assets1,331 — 1,331 709 — 709 
Long-term investments
Equity securities with readily determinable fair values(a)
3,041 3,028 13 3,876 3,849 27 
Available-for-sale debt securities:
Government and agency—non-U.S.
305 — 305 465 — 465 
Government and agency—U.S.
— — — — 
Corporate and other
74 — 74 50 — 50 
379 — 379 521 — 521 
Total long-term investments3,420 3,028 392 4,397 3,849 548 
Other noncurrent assets
Derivative assets:
Interest rate contracts
— — — 16 — 16 
Foreign exchange contracts
562 — 562 242 — 242 
Total derivative assets562 — 562 259 — 259 
Insurance contracts(b)
665 — 665 808 — 808 
Total other noncurrent assets1,227 — 1,227 1,067 — 1,067 
Total assets$35,972 $3,028 $32,944 $33,552 $3,849 $29,703 
Financial liabilities:
Other current liabilities
Derivative liabilities:
Foreign exchange contracts
$432 $— $432 $476 $— $476 
Total other current liabilities432 — 432 476 — 476 
Other noncurrent liabilities
Derivative liabilities:
Interest rate contracts206 — 206 — — — 
Foreign exchange contracts
653 — 653 405 — 405 
Total other noncurrent liabilities859 — 859 405 — 405 
Total liabilities$1,291 $— $1,291 $881 $— $881 
(a)Long-term equity securities of $144 million as of July 3, 2022 and $194 million as of December 31, 2021 were held in restricted trusts for U.S. non-qualified employee benefit plans.
(b)Includes life insurance policies held in restricted trusts for U.S. non-qualified employee benefit plans. The underlying invested assets in these contracts are marketable securities, which are carried at fair value, with changes in fair value recognized in Other (income)/deductions—net (see Note 4).
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Financial Assets and Liabilities Not Measured at Fair Value on a Recurring Basis––The carrying value of Long-term debt, excluding the current portion was $34 billion as of July 3, 2022 and $36 billion as of December 31, 2021. The estimated fair value of such debt, using a market approach and Level 2 inputs, was $34 billion as of July 3, 2022 and $42 billion as of December 31, 2021.
The differences between the estimated fair values and carrying values of held-to-maturity debt securities, private equity securities, long-term receivables and short-term borrowings not measured at fair value on a recurring basis were not significant as of July 3, 2022 and December 31, 2021. The fair value measurements of our held-to-maturity debt securities and short-term borrowings are based on Level 2 inputs. The fair value measurements of our long-term receivables and private equity securities are based on Level 3 inputs.
B. Investments
Total Short-Term, Long-Term and Equity-Method Investments
The following summarizes our investments by classification type:
(MILLIONS)July 3, 2022December 31, 2021
Short-term investments
Equity securities with readily determinable fair values(a)
$4,373 $5,365 
Available-for-sale debt securities25,621 22,014 
Held-to-maturity debt securities1,530 1,746 
Total Short-term investments$31,524 $29,125 
Long-term investments
Equity securities with readily determinable fair values$3,041 $3,876 
Available-for-sale debt securities379 521 
Held-to-maturity debt securities39 34 
Private equity securities at cost(b)
705 623 
Total Long-term investments$4,163 $5,054 
Equity-method investments14,799 16,472 
Total long-term investments and equity-method investments$18,962 $21,526 
Held-to-maturity cash equivalents$225 $268 
(a)As of July 3, 2022 and December 31, 2021, includes money market funds primarily invested in U.S. Treasury and government debt.
(b)Represent investments in the life sciences sector.
Debt Securities
At July 3, 2022, our investment portfolio consisted of debt securities issued across diverse governments, corporate and financial institutions, which are investment-grade. The contractual or estimated maturities, are as follows:
July 3, 2022December 31, 2021
Gross UnrealizedMaturities (in Years)Gross Unrealized
(MILLIONS)Amortized CostGainsLossesFair ValueWithin 1Over 1
to 5
Over 5Amortized CostGainsLossesFair Value
Available-for-sale debt securities
Government and agency––non-U.S.
$22,445 $36 $(419)$22,062 $21,758 $305 $— $18,032 $13 $(263)$17,783 
Government and agency––U.S.
2,840 — (1)2,839 2,839 — — 4,056 — (1)4,055 
Corporate and other1,098 (2)1,098 1,024 74 — 698 — (1)697 
Held-to-maturity debt securities
Time deposits and other
913 — — 913 878 23 11 947 — — 947 
Government and agency––non-U.S.
881 — — 881 876 1,102 — — 1,102 
Total debt securities$28,177 $38 $(422)$27,794 $27,376 $406 $12 $24,835 $14 $(265)$24,584 
Any expected credit losses to these portfolios would be immaterial to our financial statements.
18


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Equity Securities
The following presents the calculation of the portion of unrealized (gains)/losses that relates to equity securities, excluding equity-method investments, held at the reporting date:
Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Net (gains)/losses recognized during the period on equity securities(a)
$541 $(800)$1,241 $(1,200)
Less: Net (gains)/losses recognized during the period on equity securities sold during the period(68)24 (79)(5)
Net unrealized (gains)/losses during the reporting period on equity securities still held at the reporting date(b)
$610 $(823)$1,320 $(1,196)
(a)Reported in Other (income)/deductions––net. See Note 4.
(b)Included in net unrealized (gains)/losses are observable price changes on equity securities without readily determinable fair values. As of July 3, 2022, there were cumulative impairments and downward adjustments of $108 million and upward adjustments of $194 million. Impairments, downward and upward adjustments were not significant in the second quarter and first six months of 2022 and 2021.
C. Short-Term Borrowings
Short-term borrowings include:
(MILLIONS)July 3,
2022
December 31, 2021
Current portion of long-term debt, principal amount$1,251 $1,636 
Other short-term borrowings, principal amount(a)
4,714 605 
Total short-term borrowings, principal amount
5,965 2,241 
Net fair value adjustments related to hedging and purchase accounting25 — 
Total Short-term borrowings, including current portion of long-term debt, carried at historical proceeds, as adjusted
$5,990 $2,241 
(a)As of July 3, 2022, primarily includes $3.7 billion related to the Consumer Healthcare JV loan (see Note 2C), and cash collateral (see Note 7F). As of December 31, 2021, primarily includes cash collateral. See Note 7F.
D. Long-Term Debt
The following summarizes the aggregate principal amount of our senior unsecured long-term debt, and adjustments to report our aggregate long-term debt:
(MILLIONS)July 3,
2022
December 31, 2021
Total long-term debt, principal amount$33,352 $34,948 
Net fair value adjustments related to hedging and purchase accounting1,125 1,438 
Net unamortized discounts, premiums and debt issuance costs(185)(195)
Other long-term debt
Total long-term debt, carried at historical proceeds, as adjusted$34,294 $36,195 
E. Derivative Financial Instruments and Hedging Activities
Foreign Exchange Risk––A significant portion of our revenues, earnings and net investments in foreign affiliates is exposed to changes in foreign exchange rates. Where foreign exchange risk is not offset by other exposures, we manage our foreign exchange risk principally through the use of derivative financial instruments and foreign currency debt. These financial instruments serve to mitigate the impact on net income as a result of remeasurement into another currency, or against the impact of translation into U.S. dollars of certain foreign exchange-denominated transactions.
The derivative financial instruments primarily hedge or offset exposures in the euro, U.K. pound, Japanese yen, and Canadian dollar, and include a portion of our forecasted foreign exchange-denominated intercompany inventory sales hedged up to two years. We may seek to protect against possible declines in the reported net investments of our foreign business entities.
Interest Rate Risk––Our interest-bearing investments and borrowings are subject to interest rate risk. Depending on market conditions, we may change the profile of our outstanding debt or investments by entering into derivative financial instruments like interest rate swaps, either to hedge or offset the exposure to changes in the fair value of hedged items with fixed interest rates, or to convert variable rate debt or investments to fixed rates. The derivative financial instruments primarily hedge U.S. dollar fixed-rate debt.
19


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The following summarizes the fair value of the derivative financial instruments and notional amounts (including those reported as part of discontinued operations):
July 3, 2022December 31, 2021
Fair ValueFair Value
(MILLIONS)NotionalAssetLiabilityNotionalAssetLiability
Derivatives designated as hedging instruments:
Foreign exchange contracts(a)
$31,576 $1,642 $711 $29,576 $787 $717 
Interest rate contracts
2,250 206 2,250 21 — 
1,650 917 808 717 
Derivatives not designated as hedging instruments:
Foreign exchange contracts
$25,929 243 375 $21,419 160 164 
Total$1,893 $1,291 $968 $881 
(a)The notional amount of outstanding foreign exchange contracts hedging our intercompany forecasted inventory sales was $4.6 billion as of July 3, 2022 and $4.8 billion as of December 31, 2021.
The following summarizes information about the gains/(losses) incurred to hedge or offset operational foreign exchange or interest rate risk exposures (including those reported as part of discontinued operations):
 
Gains/(Losses)
Recognized in OID
(a)
Gains/(Losses)
Recognized in OCI
(a)
Gains/(Losses)
Reclassified from
OCI into OID and COS(a)
Three Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Derivative Financial Instruments in Cash Flow Hedge Relationships:
Foreign exchange contracts(b)
$— $— $624 $(258)$119 $13 
Amount excluded from effectiveness testing and amortized into earnings(c)
— — 27 25 
Derivative Financial Instruments in Fair Value Hedge Relationships:
Interest rate contracts
(66)26 — — — — 
Hedged item
66 (26)— — — — 
Derivative Financial Instruments in Net Investment Hedge Relationships:      
Foreign exchange contracts
— — 674 — — 
Amount excluded from effectiveness testing and amortized into earnings(c)
— — 59 36 33 26 
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:(d)
      
Foreign currency short-term borrowings— — — (11)— — 
Foreign currency long-term debt— — 48 (8)— — 
Derivative Financial Instruments Not Designated as Hedges:
Foreign exchange contracts
(394)(65)— — — — 
 $(394)$(65)$1,432 $(230)$177 $47 
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Gains/(Losses)
Recognized in OID
(a)
Gains/(Losses)
Recognized in OCI
(a)
Gains/(Losses)
Reclassified from
OCI into OID and COS(a)
Six Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Derivative Financial Instruments in Cash Flow Hedge Relationships:      
Foreign exchange contracts(b)
$— $— $811 $(56)$314 $(255)
Amount excluded from effectiveness testing and amortized into earnings(c)
— — 43 21 43 18 
Derivative Financial Instruments in Fair Value Hedge Relationships:
Interest rate contracts
(222)(1)— — — — 
Hedged item
222 — — — — 
Derivative Financial Instruments in Net Investment Hedge Relationships:
Foreign exchange contracts
— — 933 155 — — 
Amount excluded from effectiveness testing and amortized into earnings(c)
— — (15)35 63 55 
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:(d)
Foreign currency short-term borrowings— — 26 27 — — 
Foreign currency long-term debt— — 70 48 — — 
Derivative Financial Instruments Not Designated as Hedges:
Foreign exchange contracts
(413)(23)— — — — 
$(413)$(23)$1,868 $230 $421 $(182)
(a)OID = Other (income)/deductions—net, included in Other (income)/deductions—net in the condensed consolidated statements of income. COS = Cost of Sales, included in Cost of sales in the condensed consolidated statements of income. OCI = Other comprehensive income/(loss), included in the condensed consolidated statements of comprehensive income.
(b)The amounts reclassified from OCI into COS were:
a net gain of $68 million in the second quarter of 2022;
a net gain of $102 million in the first six months of 2022;
a net loss of $31 million in the second quarter of 2021; and
a net loss of $76 million in the first six months of 2021.
The remaining amounts were reclassified from OCI into OID. Based on quarter-end foreign exchange rates that are subject to change, we expect to reclassify a pre-tax gain of $725 million within the next 12 months into income. The maximum length of time over which we are hedging our exposure to the variability in future foreign exchange cash flows is approximately 21 years and relates to foreign currency debt.
(c)The amounts reclassified from OCI were reclassified into OID.
(d)Short-term borrowings and long-term debt include foreign currency borrowings, which are used in net investment hedges. The short-term borrowings’ carrying value as of December 31, 2021 was $1.1 billion. The long-term debt carrying values as of July 3, 2022 and December 31, 2021 were $774 million and $844 million, respectively.
The following summarizes cumulative basis adjustments to our debt in fair value hedges:
July 3, 2022December 31, 2021
Cumulative Amount of Fair Value Hedging Adjustment Increase/(Decrease) to
Carrying Amount
Cumulative Amount of Fair Value Hedging Adjustment Increase/(Decrease) to
Carrying Amount
(MILLIONS)
Carrying Amount of Hedged Assets/Liabilities(a)
Active Hedging RelationshipsDiscontinued Hedging Relationships
Carrying Amount of Hedged Assets/Liabilities(a)
Active Hedging RelationshipsDiscontinued Hedging Relationships
Short-term borrowings, including current portion of long-term debt$— $— $22 $— $— $— 
Long-term debt$2,234 $(206)$1,081 $2,233 $16 $1,154 
(a)Carrying amounts exclude the cumulative amount of fair value hedging adjustments.
21


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
F. Credit Risk
A significant portion of our trade accounts receivable balances are due from wholesalers and governments. For additional information on our trade accounts receivables with significant customers, see Note 13C below and Note 17C in our 2021 Form 10-K.
As of July 3, 2022, the largest investment exposures in our portfolio represent primarily sovereign debt instruments issued by France, Germany, Canada, the U.S., Japan, Switzerland and the U.K.
With respect to our derivative financial instrument agreements with financial institutions, we do not expect to incur a significant loss from failure of any counterparty. Derivative financial instruments are executed under International Swaps and Derivatives Association master agreements with credit-support annexes that contain zero threshold provisions requiring collateral to be exchanged daily depending on levels of exposure. As a result, there are no significant concentrations of credit risk with any individual financial institution. As of July 3, 2022, the aggregate fair value of these derivative financial instruments that are in a net payable position was $362 million, for which we have posted collateral of $414 million with a corresponding amount reported in Short-term investments. As of July 3, 2022, the aggregate fair value of our derivative financial instruments that are in a net receivable position was $739 million, for which we have received collateral of $755 million with a corresponding amount reported in Short-term borrowings, including current portion of long-term debt.
Note 8. Other Financial Information
A. Inventories
The following summarizes the components of Inventories:
(MILLIONS)July 3,
2022
December 31, 2021
Finished goods$3,219 $3,641 
Work-in-process5,194 4,424 
Raw materials and supplies2,041 994 
Inventories(a)
$10,454 $9,059 
Noncurrent inventories not included above(b)
$943 $939 
(a)The increase from December 31, 2021 primarily reflects higher inventory levels for Paxlovid, and increases for certain products due to network strategy and supply recovery, partially offset by decreases due to market demand.
(b)Included in Other noncurrent assets.
B. Other Current Liabilities
Other current liabilities includes, among other things, amounts payable to BioNTech for the gross profit split for Comirnaty, which totaled $7.9 billion as of July 3, 2022 and $9.7 billion as of December 31, 2021.
Note 9. Identifiable Intangible Assets
A. Identifiable Intangible Assets
The following summarizes the components of Identifiable intangible assets:
July 3, 2022December 31, 2021
(MILLIONS)Gross
Carrying
Amount
Accumulated
Amortization
Identifiable
Intangible
Assets, less
Accumulated
Amortization
Gross
Carrying
Amount
Accumulated
Amortization
Identifiable
Intangible
Assets, less
Accumulated
Amortization
Finite-lived intangible assets
Developed technology rights$73,097 $(54,903)$18,193 $73,346 $(53,732)$19,614 
Brands922 (824)98 922 (807)115 
Licensing agreements and other2,296 (1,352)945 2,284 (1,299)985 
76,315 (57,079)19,236 76,552 (55,838)20,714 
Indefinite-lived intangible assets
Brands827 827 827 827 
IPR&D(a)
8,029 8,029 3,092 3,092 
Licensing agreements and other(a)
973 973 513 513 
9,829 9,829 4,432 4,432 
Identifiable intangible assets(a), (b)
$86,144 $(57,079)$29,065 $80,984 $(55,838)$25,146 
22


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(a)The increase in the gross carrying amounts mainly reflect the impact of the acquisition of Arena. See Note 2A.
(b)The increase is primarily due to the acquisition of Arena, partially offset by amortization expense.
B. Goodwill
The following summarizes the changes in the carrying amount of Goodwill:
(MILLIONS)
Total(a)
Balance, January 1, 2022
$49,208 
Additions(b)
1,033 
Other(c)
(350)
Balance, July 3, 2022
$49,891 
(a)All goodwill is assigned within the Biopharma reportable segment.
(b)Additions relate to our acquisition of Arena. See Note 2A.
(c)Other represents the impact of foreign exchange.
Note 10. Pension and Postretirement Benefit Plans
The following summarizes the components of net periodic benefit cost/(credit):
 Pension Plans
 U.S.InternationalPostretirement
Plans
Three Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Service cost$— $— $30 $33 $$
Interest cost118 114 41 37 
Expected return on plan assets(245)(261)(77)(82)(12)(10)
Amortization of prior service cost/(credit)— — — — (31)(39)
Actuarial (gains)/losses(a)
490 — — — — 
Curtailments— — — (1)(1)— 
Special termination benefits— — — — 
Net periodic benefit cost/(credit) reported in income$365 $(142)$(6)$(14)$(30)$(32)
 Pension Plans
 U.S.InternationalPostretirement
Plans
Six Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Service cost$— $— $60 $66 $15 $18 
Interest cost236 227 82 73 14 14 
Expected return on plan assets(490)(521)(156)(164)(23)(20)
Amortization of prior service credits(1)— (1)(68)(77)
Actuarial (gains)/losses(a)
424 (45)— — — — 
Curtailments— — — (1)(14)— 
Special termination benefits12 — — 
Net periodic benefit cost/(credit) reported in income$178 $(329)$(14)$(26)$(76)$(64)
(a)Mainly reflects interim actuarial remeasurement losses in 2022, primarily driven by unfavorable plan asset performance, partially offset by gains due to an increase in interest rates.
The components of net periodic benefit cost/(credit) other than the service cost component are primarily included in Other (income)/deductions––net (see Note 4).
For the six months ended July 3, 2022, we contributed $134 million, $89 million, and $11 million to our U.S. Pension Plans, International Pension Plans, and Postretirement Plans, respectively, from our general assets, which include direct employer benefit payments.
23


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 11. Earnings Per Common Share Attributable to Pfizer Inc. Common Shareholders
The following presents the detailed calculation of EPS:
 Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
EPS Numerator––Basic
Income from continuing operations attributable to Pfizer Inc. common shareholders$9,871 $5,799 $17,743 $10,675 
Discontinued operations––net of tax34 (236)26 (235)
Net income attributable to Pfizer Inc. common shareholders$9,906 $5,563 $17,769 $10,440 
EPS Numerator––Diluted    
Income from continuing operations attributable to Pfizer Inc. common shareholders and assumed conversions$9,871 $5,799 $17,743 $10,675 
Discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders and assumed conversions34 (236)26 (235)
Net income attributable to Pfizer Inc. common shareholders and assumed conversions$9,906 $5,563 $17,769 $10,440 
EPS Denominator    
Weighted-average number of common shares outstanding––Basic5,593 5,598 5,605 5,591 
Common-share equivalents: stock options and stock issuable under employee compensation plans119 80 130 79 
Weighted-average number of common shares outstanding––Diluted5,712 5,678 5,735 5,670 
Anti-dilutive common stock equivalents(a)
— 
(a)These common stock equivalents were outstanding for the periods presented, but were not included in the computation of diluted EPS for those periods because their inclusion would have had an anti-dilutive effect.
Note 12. Contingencies and Certain Commitments
We and certain of our subsidiaries are subject to numerous contingencies arising in the ordinary course of business, including tax and legal contingencies. The following outlines our legal contingencies. For a discussion of our tax contingencies, see Note 5B.
A. Legal Proceedings
Our legal contingencies include, but are not limited to, the following:
Patent litigation, which typically involves challenges to the coverage and/or validity of patents on various products, processes or dosage forms. An adverse outcome could result in loss of patent protection for a product, a significant loss of revenues from a product or impairment of the value of associated assets. We are the plaintiff in the majority of these actions.
Product liability and other product-related litigation related to current or former products, which can include personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, among others, and often involves highly complex issues relating to medical causation, label warnings and reliance on those warnings, scientific evidence and findings, actual, provable injury and other matters.
Commercial and other asserted or unasserted matters, which can include acquisition-, licensing-, intellectual property-, collaboration- or co-promotion-related and product-pricing claims and environmental claims and proceedings, and can involve complexities that will vary from matter to matter.
Government investigations, which often are related to the extensive regulation of pharmaceutical companies by national, state and local government agencies in the U.S. and in other jurisdictions.
Certain of these contingencies could result in increased expenses and/or losses, including damages, royalty payments, fines and/or civil penalties, which could be substantial, and/or criminal charges.
We believe that our claims and defenses in matters in which we are a defendant are substantial, but litigation is inherently unpredictable and excessive verdicts do occur. We do not believe that any of these matters will have a material adverse effect on our financial position. However, we could incur judgments, enter into settlements or revise our expectations regarding the
24


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
outcome of matters, which could have a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts are accrued or paid.
We have accrued for losses that are both probable and reasonably estimable. Substantially all of our contingencies are subject to significant uncertainties and, therefore, determining the likelihood of a loss and/or the measurement of any loss can be complex. Consequently, we are unable to estimate the range of reasonably possible loss in excess of amounts accrued. Our assessments, which result from a complex series of judgments about future events and uncertainties, are based on estimates and assumptions that have been deemed reasonable by management, but that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions.
Amounts recorded for legal and environmental contingencies can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions. For proceedings under environmental laws to which a governmental authority is a party, we have adopted a disclosure threshold of $1 million in potential or actual governmental monetary sanctions.
The principal pending matters to which we are a party are discussed below. In determining whether a pending matter is a principal matter, we consider both quantitative and qualitative factors to assess materiality, such as, among others, the amount of damages and the nature of other relief sought, if specified; our view of the merits of the claims and of the strength of our defenses; whether the action purports to be, or is, a class action and, if not certified, our view of the likelihood that a class will be certified by the court; the jurisdiction in which the proceeding is pending; whether related actions have been transferred to multidistrict litigation; any experience that we or, to our knowledge, other companies have had in similar proceedings; whether disclosure of the action would be important to a reader of our financial statements, including whether disclosure might change a reader’s judgment about our financial statements in light of all of the information that is available to the reader; the potential impact of the proceeding on our reputation; and the extent of public interest in the matter. In addition, with respect to patent matters in which we are the plaintiff, we consider, among other things, the financial significance of the product protected by the patent(s) at issue. Some of the matters discussed below include those which management believes that the likelihood of possible loss in excess of amounts accrued is remote.
A1. Legal Proceedings––Patent Litigation
We are involved in suits relating to our patents, including but not limited to, those discussed below. Most involve claims by generic drug manufacturers that patents covering our products (or those of our collaboration/licensing partners to which we have licenses or co-promotion rights and to which we may or may not be a party), processes or dosage forms are invalid and/or do not cover the product of the generic drug manufacturer. Also, counterclaims, as well as various independent actions, have been filed alleging that our assertions of, or attempts to enforce, patent rights with respect to certain products constitute unfair competition and/or violations of antitrust laws. In addition to the challenges to the U.S. patents that are discussed below, patent rights to certain of our products or those of our collaboration/licensing partners are being challenged in various other jurisdictions. Some of our collaboration or licensing partners face challenges to the validity of their patent rights in non-U.S. jurisdictions. For example, in April 2022, the U.K. High Court issued a judgment finding invalid a BMS patent related to Eliquis due to expire in 2026. BMS is seeking permission to appeal the High Court’s decision. Additional challenges remain pending in other jurisdictions. Also, for example, in July 2022, CureVac AG (CureVac) brought a patent infringement action against BioNTech and certain of its subsidiaries in the German Regional Court alleging that Comirnaty infringes three German utility model patents and one expired European patent. Additional challenges involving Comirnaty patents may be filed against us and/or BioNTech in other jurisdictions in the future. Adverse decisions in these matters could have a material adverse effect on our results of operations. We are also party to patent damages suits in various jurisdictions pursuant to which generic drug manufacturers, payers, governments or other parties are seeking damages from us for allegedly causing delay of generic entry.

We also are often involved in other proceedings, such as inter partes review, post-grant review, re-examination or opposition proceedings, before the U.S. Patent and Trademark Office, the European Patent Office, or other foreign counterparts relating to our intellectual property or the intellectual property rights of others. Also, if one of our patents is found to be invalid by such proceedings, generic or competitive products could be introduced into the market resulting in the erosion of sales of our existing products. For example, several of the patents in our pneumococcal vaccine portfolio have been challenged in inter partes review and post-grant review proceedings in the U.S. Patent and Trademark Office. In addition, another patent was challenged in federal court in Delaware; and that case was settled in September 2021 on terms not material to the company. Other challenges to pneumococcal vaccine patents remain pending at the Patent Trial and Appeal Board and outside the U.S. The invalidation of any of the patents in our pneumococcal portfolio could potentially allow additional competitor vaccines, if approved, to enter the marketplace earlier than anticipated. In the event that any of the patents are found valid and infringed, a competitor’s vaccine, if approved, might be prohibited from entering the market or a competitor might be required to pay us a royalty.

25


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
We are also subject to patent litigation pursuant to which one or more third parties seek damages and/or injunctive relief to compensate for alleged infringement of its patents by our commercial or other activities. For example, our Hospira subsidiaries are involved in patent and patent-related disputes over their attempts to bring generic pharmaceutical products to market. If one of our marketed products is found to infringe valid patent rights of a third party, such third party may be awarded significant damages or royalty payments, or we may be prevented from further sales of that product. Such damages may be enhanced as much as three-fold if we or one of our subsidiaries is found to have willfully infringed valid patent rights of a third party.
Actions In Which We Are The Plaintiff
EpiPen
In 2010, King, which we acquired in 2011 and is a wholly-owned subsidiary, brought a patent-infringement action against Sandoz in the U.S. District Court for the District of New Jersey in connection with Sandoz’s abbreviated new drug application (ANDA) filed with the FDA seeking approval to market an epinephrine injectable product. Sandoz is challenging patents, which expire in 2025, covering the next-generation autoinjector for use with epinephrine that is sold under the EpiPen brand name. We expect that the outcome of this matter will not be material to us.
Xeljanz (tofacitinib)
Beginning in 2017, we brought patent-infringement actions against several generic manufacturers that filed separate ANDAs with the FDA seeking approval to market their generic versions of tofacitinib tablets in one or both of 5 mg and 10 mg dosage strengths, and in both immediate and extended release forms. To date, we have settled actions with several manufacturers on terms not material to us. The remaining actions continue in the U.S. District Court for the District of Delaware as described below.
In October 2021, we brought a separate patent-infringement action against Sinotherapeutics Inc. (Sinotherapeutics) asserting the infringement and validity of our patent covering extended release formulations of tofacitinib that was challenged by Sinotherapeutics in its ANDA seeking approval to market a generic version of tofacitinib 11 mg extended release tablets.
In February 2022, we brought a separate patent-infringement action against Slayback Pharma LLC (Slayback) asserting the infringement and validity of our compound patent covering the active ingredient that was challenged by Slayback in its ANDA seeking approval to market a generic version of tofacitinib oral solution 1 mg/mL. In May 2022, we settled our action against Slayback on terms not material to us.
In June 2022, we brought a separate patent infringement action against MSN Laboratories Private Ltd. (MSN) asserting the infringement and validity of our compound patent covering the active agreement that was challenged by MSN in its ANDAs seeking approval to market generic versions of tofacitinib immediate release tablets (5 mg, 10 mg) and oral solution 1 mg/mL.
Inlyta (axitinib)
In 2019, Glenmark Pharmaceuticals Ltd. (Glenmark) notified us that it had filed an ANDA with the FDA seeking approval to market a generic version of Inlyta. Glenmark asserts the invalidity and non-infringement of the crystalline form patent for Inlyta that expires in 2030. In 2019, we filed suit against Glenmark in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the crystalline form patent for Inlyta.
Ibrance (palbociclib)
Beginning in September 2020, we received correspondence from several generic companies notifying us that they would seek approval to market generic versions of Ibrance capsules. The generic companies assert the invalidity and non-infringement of our crystalline form patent which expires in 2034. Beginning in October 2020, we brought patent infringement actions against each of these generic companies in various federal courts, asserting the validity and infringement of the crystalline form patent. We have settled with certain of these generic companies on terms not material to us, and we dismissed the patent infringement actions against the remaining generic companies.
Beginning in January 2021, several generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Ibrance tablets. The generic companies are challenging some or all of the following patents: (i) the composition of matter patent expiring in 2027; (ii) the composition of matter patent expiring in 2023; (iii) the method of use patent expiring in 2023; (iv) the crystalline form patent expiring in 2034; and (v) a tablet formulation patent expiring in 2036. We brought patent infringement actions against each of the generic filers in various federal courts, asserting the validity and infringement of the patents challenged by the generic companies. We have settled with one of these generic companies on terms not material to us, and we dismissed the patent infringement actions relating to the crystalline form of patent, the composition of matter patent expiring in 2023, and the method of use patent against the generic companies that had challenged these patents.
Eucrisa
Beginning in September 2021, several generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Eucrisa. The companies assert the invalidity and non-infringement of a composition of
26


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
matter patent expiring in 2026, two method of use patents expiring in 2027, and one other method of use patent expiring in 2030. In September 2021, we brought patent infringement actions against the generic filers in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the patents challenged by the generic companies.
Actions in Which We are the Defendant
Comirnaty
In March 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) filed a complaint in the U.S. District Court for the District of Delaware against Pfizer and Pharmacia & Upjohn Co. LLC, our wholly owned subsidiary, alleging that Comirnaty infringes U.S. Patent No. 11,246,933, which was issued in February 2022, and seeking unspecified monetary damages. In July 2022, Alnylam filed a second complaint in the U.S. District Court for the District of Delaware against Pfizer, Pharmacia & Upjohn Co. LLC, BioNTech and BioNTech Manufacturing GmbH, alleging that Comirnaty infringes U.S. Patent No. 11,382,979, which was issued in July 2022, and seeking unspecified monetary damages.
Paxlovid
In June 2022, Enanta Pharmaceuticals, Inc. filed a complaint in the U.S. District Court for the District of Massachusetts against Pfizer alleging that the active ingredient in Paxlovid, nirmatrelvir, infringes U.S. Patent No. 11,358,953, which was issued in June 2022, and seeking unspecified monetary damages.
Matters Involving Pfizer and its Collaboration/Licensing Partners
Eliquis
In 2017, twenty-five generic companies sent BMS Paragraph-IV certification letters informing BMS that they had filed ANDAs seeking approval of generic versions of Eliquis, challenging the validity and infringement of one or more of the three patents listed in the Orange Book for Eliquis. One of the patents expired in December 2019 and the remaining patents currently are set to expire in 2026 and 2031. Eliquis has been jointly developed and is being commercialized by BMS and Pfizer. BMS and Pfizer filed patent-infringement actions against all generic filers in the U.S. District Court for the District of Delaware and the U.S. District Court for the District of West Virginia, asserting that each of the generic companies’ proposed products would infringe each of the patent(s) that each generic filer challenged. Some generic filers challenged only the 2031 patent, some challenged both the 2031 and 2026 patent, and one generic company challenged all three patents. In August 2020, the U.S. District Court for the District of Delaware ruled that both the 2026 patent and the 2031 patent are valid and infringed by the proposed generic products. In August and September 2020, the generic filers appealed the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit. Prior to the August 2020 ruling, we and BMS settled with certain of the companies on terms not material to us, and we and BMS may settle with other generic companies in the future. In September 2021, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court’s decision.
Comirnaty
In July 2022, Pfizer, BioNTech and BioNTech Manufacturing GmbH filed a declaratory judgment complaint against CureVac in the U.S. District Court for the District of Massachusetts seeking a judgment of non-infringement for the following three patents relating to Comirnaty: U.S. Patent Nos. 11,135,312, 11,149,278, and 11,241,493.
A2. Legal Proceedings––Product Litigation
We are defendants in numerous cases, including but not limited to those discussed below, related to our pharmaceutical and other products. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss.
Asbestos
Between 1967 and 1982, Warner-Lambert owned American Optical Corporation (American Optical), which manufactured and sold respiratory protective devices and asbestos safety clothing. In connection with the sale of American Optical in 1982, Warner-Lambert agreed to indemnify the purchaser for certain liabilities, including certain asbestos-related and other claims. Warner-Lambert was acquired by Pfizer in 2000 and is a wholly owned subsidiary of Pfizer. Warner-Lambert is actively engaged in the defense of, and will continue to explore various means of resolving, these claims.

Numerous lawsuits against American Optical, Pfizer and certain of its previously owned subsidiaries are pending in various federal and state courts seeking damages for alleged personal injury from exposure to products allegedly containing asbestos and other allegedly hazardous materials sold by Pfizer and certain of its previously owned subsidiaries.
There also are a small number of lawsuits pending in various federal and state courts seeking damages for alleged exposure to asbestos in facilities owned or formerly owned by Pfizer or its subsidiaries.
27


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Effexor
Beginning in 2011, actions, including purported class actions, were filed in various federal courts against Wyeth and, in certain of the actions, affiliates of Wyeth and certain other defendants relating to Effexor XR, which is the extended-release formulation of Effexor. The plaintiffs in each of the class actions seek to represent a class consisting of all persons in the U.S. and its territories who directly purchased, indirectly purchased or reimbursed patients for the purchase of Effexor XR or generic Effexor XR from any of the defendants from June 14, 2008 until the time the defendants’ allegedly unlawful conduct ceased. The plaintiffs in all of the actions allege delay in the launch of generic Effexor XR in the U.S. and its territories, in violation of federal antitrust laws and, in certain of the actions, the antitrust, consumer protection and various other laws of certain states, as the result of Wyeth fraudulently obtaining and improperly listing certain patents for Effexor XR in the Orange Book, enforcing certain patents for Effexor XR and entering into a litigation settlement agreement with a generic drug manufacturer with respect to Effexor XR. Each of the plaintiffs seeks treble damages (for itself in the individual actions or on behalf of the putative class in the purported class actions) for alleged price overcharges for Effexor XR or generic Effexor XR in the U.S. and its territories since June 14, 2008. All of these actions have been consolidated in the U.S. District Court for the District of New Jersey.
In 2014, the District Court dismissed the direct purchaser plaintiffs’ claims based on the litigation settlement agreement, but declined to dismiss the other direct purchaser plaintiff claims. In 2015, the District Court entered partial final judgments as to all settlement agreement claims, including those asserted by direct purchasers and end-payer plaintiffs, which plaintiffs appealed to the U.S. Court of Appeals for the Third Circuit. In 2017, the U.S. Court of Appeals for the Third Circuit reversed the District Court’s decisions and remanded the claims to the District Court.
Lipitor
Beginning in 2011, purported class actions relating to Lipitor were filed in various federal courts against, among others, Pfizer, certain Pfizer affiliates, and, in most of the actions, Ranbaxy Laboratories Ltd. (Ranbaxy) and certain Ranbaxy affiliates. The plaintiffs in these various actions seek to represent nationwide, multi-state or statewide classes consisting of persons or entities who directly purchased, indirectly purchased or reimbursed patients for the purchase of Lipitor (or, in certain of the actions, generic Lipitor) from any of the defendants from March 2010 until the cessation of the defendants’ allegedly unlawful conduct (the Class Period). The plaintiffs allege delay in the launch of generic Lipitor, in violation of federal antitrust laws and/or state antitrust, consumer protection and various other laws, resulting from (i) the 2008 agreement pursuant to which Pfizer and Ranbaxy settled certain patent litigation involving Lipitor and Pfizer granted Ranbaxy a license to sell a generic version of Lipitor in various markets beginning on varying dates, and (ii) in certain of the actions, the procurement and/or enforcement of certain patents for Lipitor. Each of the actions seeks, among other things, treble damages on behalf of the putative class for alleged price overcharges for Lipitor (or, in certain of the actions, generic Lipitor) during the Class Period. In addition, individual actions have been filed against Pfizer, Ranbaxy and certain of their affiliates, among others, that assert claims and seek relief for the plaintiffs that are substantially similar to the claims asserted and the relief sought in the purported class actions described above. These various actions have been consolidated for pre-trial proceedings in a Multi-District Litigation in the U.S. District Court for the District of New Jersey.
In September 2013 and 2014, the District Court dismissed with prejudice the claims of the direct purchasers. In October and November 2014, the District Court dismissed with prejudice the claims of all other Multi-District Litigation plaintiffs. All plaintiffs appealed the District Court’s orders dismissing their claims with prejudice to the U.S. Court of Appeals for the Third Circuit. In addition, the direct purchaser class plaintiffs appealed the order denying their motion to amend the judgment and for leave to amend their complaint to the Court of Appeals. In 2017, the Court of Appeals reversed the District Court’s decisions and remanded the claims to the District Court.
Also, in 2013, the State of West Virginia filed an action in West Virginia state court against Pfizer and Ranbaxy, among others, that asserts claims and seeks relief on behalf of the State of West Virginia and residents of that state that are substantially similar to the claims asserted and the relief sought in the purported class actions described above.
EpiPen (Direct Purchaser)
In February 2020, a lawsuit was filed in the U.S. District Court for the District of Kansas against Pfizer, its current and former affiliates King and Meridian, and various Mylan entities, on behalf of a purported U.S. nationwide class of direct purchaser plaintiffs who purchased EpiPen devices directly from the defendants. Plaintiffs in this action generally allege that Pfizer and Mylan conspired to delay market entry of generic EpiPen through the settlement of patent litigation regarding EpiPen, and thereby delayed market entry of generic EpiPen in violation of federal antitrust law. Plaintiffs seek treble damages for alleged overcharges for EpiPen since 2011. In July 2021, the District Court granted defendants’ motion to dismiss the direct purchaser complaint, without prejudice. In September 2021, plaintiffs filed an amended complaint. In August 2022, the District Court granted Pfizer’s motion to dismiss the complaint.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Nexium 24HR and Protonix
A number of individual and multi-plaintiff lawsuits have been filed against Pfizer, certain of its subsidiaries and/or other pharmaceutical manufacturers in various federal and state courts alleging that the plaintiffs developed kidney-related injuries purportedly as a result of the ingestion of certain proton pump inhibitors. The cases against Pfizer involve Protonix and/or Nexium 24HR and seek compensatory and punitive damages and, in some cases, treble damages, restitution or disgorgement. In 2017, the federal actions were ordered transferred for coordinated pre-trial proceedings to a Multi-District Litigation in the U.S. District Court for the District of New Jersey. As part of our Consumer Healthcare JV transaction with GSK, the JV has agreed to assume, and to indemnify Pfizer for, liabilities arising out of such litigation to the extent related to Nexium 24HR.
Docetaxel
Personal Injury Actions
A number of lawsuits have been filed against Hospira and Pfizer in various federal and state courts alleging that plaintiffs who were treated with Docetaxel developed permanent hair loss. The significant majority of the cases also name other defendants, including the manufacturer of the branded product, Taxotere. Plaintiffs seek compensatory and punitive damages.
In 2016, the federal cases were transferred for coordinated pre-trial proceedings to a Multi-District Litigation in the U.S. District Court for the Eastern District of Louisiana.
Mississippi Attorney General Government Action
In 2018, the Attorney General of Mississippi filed a complaint in Mississippi state court against the manufacturer of the branded product and eight other manufacturers including Pfizer and Hospira, alleging, with respect to Pfizer and Hospira, a failure to warn about a risk of permanent hair loss in violation of the Mississippi Consumer Protection Act. The action seeks civil penalties and injunctive relief.
Zantac
A number of lawsuits have been filed against Pfizer in various federal and state courts alleging that plaintiffs developed various types of cancer, or face an increased risk of developing cancer, purportedly as a result of the ingestion of Zantac. The significant majority of these cases also name other defendants that have historically manufactured and/or sold Zantac. Pfizer has not sold Zantac since 2006, and only sold an OTC version of the product. Plaintiffs seek compensatory and punitive damages.
In February 2020, the federal actions were transferred for coordinated pre-trial proceedings to a Multi-District Litigation in the U.S. District Court for the Southern District of Florida. Plaintiffs in the Multi-District Litigation have filed against Pfizer and many other defendants a master personal injury complaint, asserting a consolidated consumer class action alleging, among other things, claims under consumer protection statutes of all 50 states, and a medical monitoring complaint seeking to certify medical monitoring classes under the laws of 13 states. In addition, (i) Pfizer has received service of Canadian class action complaints naming Pfizer and other defendants, and seeking compensatory and punitive damages for personal injury and economic loss, allegedly arising from the defendants’ sale of Zantac in Canada; and (ii) the State of New Mexico and the Mayor and City Council of Baltimore separately filed civil actions against Pfizer and many other defendants in state court, alleging various state statutory and common law claims in connection with the defendants’ alleged sale of Zantac in those jurisdictions. In April 2021, a Judicial Council Coordinated Proceeding was created in the Superior Court of California in Alameda County to coordinate personal injury actions against Pfizer and other defendants filed in California state court.
Chantix
Beginning in August 2021, a number of putative class actions have been filed against Pfizer in various U.S. federal courts following Pfizer’s voluntary recall of Chantix due to the presence of a nitrosamine, N-nitroso-varenicline. Plaintiffs assert that they suffered economic harm purportedly as a result of purchasing Chantix or generic varenicline medicines sold by Pfizer. Plaintiffs seek to represent nationwide and state-specific classes and seek various remedies, including damages and medical monitoring. Similar putative class actions have been filed in Canada and Israel, where the product brand is Champix.
A3. Legal Proceedings––Commercial and Other Matters
Monsanto-Related Matters
In 1997, Monsanto Company (Former Monsanto) contributed certain chemical manufacturing operations and facilities to a newly formed corporation, Solutia Inc. (Solutia), and spun off the shares of Solutia. In 2000, Former Monsanto merged with Pharmacia & Upjohn Company to form Pharmacia. Pharmacia then transferred its agricultural operations to a newly created subsidiary, named Monsanto Company (New Monsanto), which it spun off in a two-stage process that was completed in 2002. Pharmacia was acquired by Pfizer in 2003 and is a wholly owned subsidiary of Pfizer.
In connection with its spin-off that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities related to Pharmacia’s former agricultural business. New Monsanto has defended and/or is defending Pharmacia
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
in connection with various claims and litigation arising out of, or related to, the agricultural business, and has been indemnifying Pharmacia when liability has been imposed or settlement has been reached regarding such claims and litigation.
In connection with its spin-off in 1997, Solutia assumed, and agreed to indemnify Pharmacia for, liabilities related to Former Monsanto’s chemical businesses. As the result of its reorganization under Chapter 11 of the U.S. Bankruptcy Code, Solutia’s indemnification obligations relating to Former Monsanto’s chemical businesses are primarily limited to sites that Solutia has owned or operated. In addition, in connection with its spin-off that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities primarily related to Former Monsanto’s chemical businesses, including, but not limited to, any such liabilities that Solutia assumed. Solutia’s and New Monsanto’s assumption of, and agreement to indemnify Pharmacia for, these liabilities apply to pending actions and any future actions related to Former Monsanto’s chemical businesses in which Pharmacia is named as a defendant, including, without limitation, actions asserting environmental claims, including alleged exposure to polychlorinated biphenyls. Solutia and/or New Monsanto are defending Pharmacia in connection with various claims and litigation arising out of, or related to, Former Monsanto’s chemical businesses, and have been indemnifying Pharmacia when liability has been imposed or settlement has been reached regarding such claims and litigation.
Environmental Matters
In 2009, we submitted a revised site-wide feasibility study with regard to the Wyeth Holdings Corporation (formerly, American Cyanamid Company) discontinued industrial chemical facility in Bound Brook, New Jersey. In 2011, Wyeth Holdings Corporation executed an Administrative Settlement Agreement and Order on Consent for Removal Action (the 2011 Administrative Settlement Agreement) with the U.S. Environmental Protection Agency (EPA) with regard to the Bound Brook facility. In accordance with the 2011 Administrative Settlement Agreement, we completed construction of an interim remedy. In 2012, the EPA issued a final remediation plan for the Bound Brook facility’s main plant area. In 2013, Wyeth Holdings Corporation (now Wyeth Holdings LLC) entered into an Administrative Settlement Agreement and Order on Consent with the EPA to allow us to undertake detailed engineering design of the remedy for the main plant area and to perform a focused feasibility study for two adjacent lagoons. In 2015, the U.S., on behalf of the EPA, filed a complaint and consent decree with the federal District Court for the District of New Jersey that allows Wyeth Holdings LLC to complete the design and to implement the remedy for the main plant area. The consent decree (which supersedes the 2011 Administrative Settlement Agreement) was entered by the District Court in 2015. In 2018, the EPA issued a final remediation plan for the two adjacent lagoons. In 2019, Wyeth Holdings LLC entered into an Administrative Settlement Agreement and Order on Consent with the EPA to allow us to undertake detailed engineering design of the remedy for the lagoons. In September 2021, the U.S., on behalf of the EPA, filed a complaint and consent decree with the federal District Court for the District of New Jersey, which the court approved in November 2021, that will allow Wyeth Holdings LLC to complete the design and implement the remedy for the two adjacent lagoons.
We have accrued for the estimated costs of the site remedies for the Bound Brook facility.
We are a party to a number of other proceedings brought under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, and other state, local or foreign laws in which the primary relief sought is the cost of past and/or future remediation.
Contracts with Iraqi Ministry of Health
In 2017, a number of U.S. service members, civilians, and their families brought a complaint in the U.S. District Court for the District of Columbia against a number of pharmaceutical and medical devices companies, including Pfizer and certain of its subsidiaries, alleging that the defendants violated the U.S. Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health, and seeks monetary relief. In July 2020, the District Court granted defendants’ motions to dismiss and dismissed all of plaintiffs’ claims. In January 2022, the Court of Appeals reversed the District Court’s decision. In February 2022, the defendants filed for en banc review of the Court of Appeals’ decision.
Allergan Complaint for Indemnity
In 2019, Pfizer was named as a defendant in a complaint, along with King, filed by Allergan Finance LLC (Allergan) in the Supreme Court of the State of New York, asserting claims for indemnity related to Kadian, which was owned for a short period by King in 2008, prior to Pfizer's acquisition of King in 2010. This suit was voluntarily discontinued without prejudice in January 2021.
Viatris Securities Litigation
In October 2021, a putative class action was filed in the Court of Common Pleas of Allegheny County, Pennsylvania on behalf of former Mylan N.V. shareholders who received Viatris common stock in exchange for Mylan shares in connection with the spin-off of the Upjohn Business and its combination with Mylan (the Transactions). Viatris, Pfizer, and certain of each
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
company’s current and former officers, directors and employees are named as defendants. The complaint alleges that the defendants violated certain provisions of the Securities Act of 1933 in connection with certain disclosures made in or omitted from the registration statement and related prospectus issued in connection with the Transactions. Plaintiff seeks damages, costs and expenses and other equitable and injunctive relief.
A4. Legal Proceedings––Government Investigations
We are subject to extensive regulation by government agencies in the U.S., other developed markets and multiple emerging markets in which we operate. Criminal charges, substantial fines and/or civil penalties, limitations on our ability to conduct business in applicable jurisdictions, corporate integrity or deferred prosecution agreements, as well as reputational harm and increased public interest in the matter could result from government investigations in the U.S. and other jurisdictions in which we do business. These matters often involve government requests for information on a voluntary basis or through subpoenas after which the government may seek additional information through follow-up requests or additional subpoenas. In addition, in a qui tam lawsuit in which the government declines to intervene, the relator may still pursue a suit for the recovery of civil damages and penalties on behalf of the government. Among the investigations by government agencies are the matters discussed below.
Greenstone Investigations
U.S. Department of Justice Antitrust Division Investigation
Since July 2017, the U.S. Department of Justice's Antitrust Division has been investigating our former Greenstone generics business. We believe this is related to an ongoing broader antitrust investigation of the generic pharmaceutical industry. We have produced records relating to this investigation.
State Attorneys General and Multi-District Generics Antitrust Litigation
In April 2018, Greenstone received requests for information from the Antitrust Department of the Connecticut Office of the Attorney General. In May 2019, Attorneys General of more than 40 states plus the District of Columbia and Puerto Rico filed a complaint against a number of pharmaceutical companies, including Greenstone and Pfizer. The matter has been consolidated with a Multi-District Litigation in the Eastern District of Pennsylvania. As to Greenstone and Pfizer, the complaint alleges anticompetitive conduct in violation of federal and state antitrust laws and state consumer protection laws. In June 2020, the State Attorneys General filed a new complaint against a large number of companies, including Greenstone and Pfizer, making similar allegations, but concerning a new set of drugs. This complaint was transferred to the Multi-District Litigation in July 2020. The Multi-District Litigation also includes civil complaints filed by private plaintiffs and state counties against Pfizer, Greenstone and a significant number of other defendants asserting allegations that generally overlap with those asserted by the State Attorneys General.
Subpoena relating to Manufacturing of Quillivant XR
In October 2018, we received a subpoena from the U.S. Attorney’s Office for the Southern District of New York (SDNY) seeking records relating to our relationship with another drug manufacturer and its production and manufacturing of drugs including, but not limited to, Quillivant XR. We have produced records pursuant to the subpoena.
Government Inquiries relating to Meridian Medical Technologies
In February 2019, we received a civil investigative demand from the U.S. Attorney’s Office for the SDNY. The civil investigative demand seeks records and information related to alleged quality issues involving the manufacture of auto-injectors at the Meridian site. In August 2019, we received a HIPAA subpoena from the U.S. Attorney’s Office for the Eastern District of Missouri seeking similar records and information. We are producing records in response to these requests.
U.S. Department of Justice/SEC Inquiry relating to Russian Operations
In June 2019, we received an informal request from the U.S. Department of Justice’s Foreign Corrupt Practices Act (FCPA) Unit seeking documents relating to our operations in Russia. In September 2019, we received a similar request from the SEC’s FCPA Unit. We have produced records pursuant to these requests.
Docetaxel––Mississippi Attorney General Government Investigation
See Legal Proceedings––Product Litigation––Docetaxel––Mississippi Attorney General Government Investigation above for information regarding a government investigation related to Docetaxel marketing practices.
U.S. Department of Justice Inquiries relating to India Operations
In March 2020, we received an informal request from the U.S. Department of Justice's Consumer Protection Branch seeking documents relating to our manufacturing operations in India, including at our former facility located at Irrungattukottai in India. In April 2020, we received a similar request from the U.S. Attorney’s Office for the SDNY regarding a civil investigation concerning operations at our facilities in India. We are producing records pursuant to these requests.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
U.S. Department of Justice/SEC Inquiry relating to China Operations
In June 2020, we received an informal request from the U.S. Department of Justice's FCPA Unit seeking documents relating to our operations in China. In August 2020, we received a similar request from the SEC’s FCPA Unit. We are producing records pursuant to these requests.
Zantac––State of New Mexico and Mayor and City Council of Baltimore Civil Actions
See Legal Proceedings––Product Litigation––Zantac above for information regarding civil actions separately filed by the State of New Mexico and the Mayor and City Council of Baltimore alleging various state statutory and common law claims in connection with the defendants’ alleged sale of Zantac in those jurisdictions.
B. Guarantees and Indemnifications
In the ordinary course of business and in connection with the sale of assets and businesses and other transactions, we often indemnify our counterparties against certain liabilities that may arise in connection with the transaction or that are related to events and activities prior to or following a transaction. If the indemnified party were to make a successful claim pursuant to the terms of the indemnification, we may be required to reimburse the loss. These indemnifications are generally subject to various restrictions and limitations. Historically, we have not paid significant amounts under these provisions and, as of July 3, 2022, the estimated fair value of these indemnification obligations is not material to Pfizer. See Note 2C for a description of the March 2022 indemnity provided by Pfizer to GSK in connection with the issuance of notes by the Consumer Healthcare JV. In conjunction with the completion of GSK’s demerger transactions in July 2022, GSK’s guarantee and our related indemnification of GSK’s guarantee were terminated.
In addition, in connection with our entry into certain agreements and other transactions, our counterparties may be obligated to indemnify us. For example, in November 2020, we and Mylan completed the transaction to spin-off our Upjohn Business and combine it with Mylan to form Viatris. As part of the transaction and as previously disclosed, each of Viatris and Pfizer has agreed to assume, and to indemnify the other for, liabilities arising out of certain matters. Also, our global agreement with BioNTech to co-develop a mRNA-based coronavirus vaccine program aimed at preventing COVID-19 infection, includes certain indemnity provisions pursuant to which each of BioNTech and Pfizer has agreed to indemnify the other for certain liabilities that may arise in connection with certain third-party claims relating to Comirnaty.
We have also guaranteed the long-term debt of certain companies that we acquired and that now are subsidiaries of Pfizer. See Note 7D.
C. Contingent Consideration for Acquisitions
We may be required to make payments to sellers for certain prior business combinations that are contingent upon future events or outcomes. For additional information, see Note 1E in our 2021 Form 10-K.
Note 13. Segment, Geographic and Other Revenue Information
A. Segment Information
We manage our commercial operations through two operating segments: Biopharma and PC1. The Biopharma and PC1 segments are each led by a single manager. Biopharma is the only reportable segment. Biopharma is a science-based medicines business that includes six therapeutic areas – Vaccines, Hospital, Oncology, Internal Medicine, Rare Disease, and Inflammation & Immunology. The Hospital therapeutic area commercializes our global portfolio of sterile injectable and anti-infective medicines, as well as an oral COVID-19 treatment.
Each operating segment has responsibility for its commercial activities. Regional commercial organizations market, distribute and sell our products and are supported by global platform functions that are responsible for the research, development, manufacturing and supply of our products and global corporate enabling functions. Biopharma receives its R&D services from WRDM and GPD. These services include IPR&D projects for new investigational products and additional indications for in-line products. Each operating segment has a geographic footprint across developed and emerging markets. Our chief operating decision maker uses the revenues and earnings of the operating segments, among other factors, for performance evaluation and resource allocation.
Other Costs and Business Activities––Certain pre-tax costs are not allocated to our operating segment results, such as costs associated with: (i) R&D and medical expenses managed by our WRDM and GPD organizations, (ii) corporate enabling functions and other corporate costs, (iii) overhead costs primarily associated with our manufacturing operations, (iv) our share of earnings from the Consumer Healthcare JV, as well as (v) all amortization of intangible assets, acquisition-related items, and certain significant items representing substantive and/or unusual, and in some cases recurring, items that are evaluated on an
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
individual basis by management and that, either as a result of their nature or size, would not be expected to occur as part of our normal business on a regular basis. Beginning in the first quarter of 2022, acquisition-related items may now include purchase accounting impacts that previously would have been included as part of a reconciling item entitled “Purchase accounting adjustments” that we no longer separately present, such as: (i) the incremental charge to cost of sales from the sale of acquired inventory that was written up to fair value, (ii) depreciation related to the increase/decrease in fair value of acquired fixed assets, (iii) amortization related to the increase in fair value of acquired debt and (iv) the fair value changes for contingent consideration. The operating results of PC1, our global contract development and manufacturing organization, are included in Other business activities.
Segment Assets––We manage our assets on a total company basis, not by operating segment, as our operating assets are shared or commingled. Therefore, our chief operating decision maker does not regularly review any asset information by operating segment and, accordingly, we do not report asset information by operating segment. Total assets were $195 billion as of July 3, 2022 and $181 billion as of December 31, 2021.
Selected Income Statement Information
The following provides selected income statement information by reportable segment:
Three Months EndedSix Months Ended
 Revenues
Earnings(a)
Revenues
Earnings(a)
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Reportable Segment:
Biopharma$27,425 $18,463 $17,223 $9,816 $52,748 $32,588 $30,662 $18,199 
Other business activities(b)
317 437 (3,441)(2,524)655 827 (5,917)(4,571)
Reconciling Items:
Amortization of intangible assets— — (822)(928)— — (1,657)(1,798)
Acquisition-related items— — (82)(34)— — (269)27 
Certain significant items(c)
— — (1,431)618 — — (2,322)784 
$27,742 $18,899 $11,447 $6,949 $53,402 $33,415 $20,497 $12,641 
(a)Income from continuing operations before provision/(benefit) for taxes on income. Biopharma’s earnings include dividend income from our investment in ViiV of $69 million in the second quarter of 2022 and $62 million in the second quarter of 2021, and $125 million in the first six months of 2022 and $89 million in the first six months of 2021.
(b)Other business activities include revenues and costs associated with PC1, as well as costs that we do not allocate to our operating segments, per above. Included in earnings in the second quarter and first six months of 2022 is a $450 million write-off to Cost of sales of inventory related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used.
(c)Certain significant items are substantive and/or unusual, and in some cases recurring, items (as noted above). For earnings in the second quarter and first six months of 2022, includes, among other items, net losses on equity securities of $539 million and $1.2 billion, respectively, recorded in Other (income)/deductions––net. For earnings in the second quarter and first six months of 2021, includes, among other items, net gains on equity securities of $798 million and $1.2 billion, respectively, recorded in Other (income)/deductions––net.
B. Geographic Information
The following summarizes revenues by geographic area:
 Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
%
Change
July 3,
2022
July 4,
2021
%
Change
United States$11,222 $7,515 49 $20,140 $15,046 34 
Developed Europe5,480 4,577 20 11,569 7,615 52 
Developed Rest of World5,034 2,997 68 8,320 4,120 102 
Emerging Markets6,006 3,810 58 13,373 6,634 102 
Revenues$27,742 $18,899 47 $53,402 $33,415 60 
C. Other Revenue Information
Significant Customers––For information on our significant wholesale customers, see Note 17C in our 2021 Form 10-K. Additionally, revenues from the U.S. government represented 26% and 22% of total revenues for the three and six months ended July 3, 2022, respectively, and primarily represent sales of Comirnaty and Paxlovid. Accounts receivable from the U.S.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
government represented 23% of total trade accounts receivable as of July 3, 2022, and primarily relate to sales of Comirnaty and Paxlovid.
Significant Product Revenues
The following provides detailed revenue information for several of our major products:
(MILLIONS)Three Months EndedSix Months Ended
PRODUCTPRIMARY INDICATION OR CLASSJuly 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
TOTAL REVENUES(a)
$27,742 $18,899 $53,402 $33,415 
PFIZER BIOPHARMACEUTICALS GROUP (BIOPHARMA)(a), (b)
$27,425 $18,463 $52,748 $32,588 
Vaccines$10,459 $9,234 $25,399 $14,127 
Comirnaty direct sales and alliance revenues
Active immunization to prevent COVID-19
8,848 7,838 22,075 11,300 
Prevnar family(c)
Pneumococcal disease1,429 1,241 2,994 2,524 
NimenrixMeningococcal ACWY disease65 49 142 95 
FSME-IMMUN/TicoVacTick-borne encephalitis disease68 61 110 114 
All other VaccinesVarious49 46 78 94 
Hospital(a)
$9,714 $1,745 $12,905 $3,630 
PaxlovidCOVID-19 infection (high risk population)8,115 — 9,585 — 
SulperazonBacterial infections210 141 420 334 
Ig Portfolio(d)
Various125 107 232 212 
ZaviceftaBacterial infections100 104 204 198 
ZithromaxBacterial infections54 43 180 132 
MedrolAnti-inflammatory glucocorticoid79 112 155 211 
FragminTreatment/prevention of venous thromboembolism72 77 142 149 
VfendFungal infections54 72 119 153 
All other Anti-infectivesVarious367 474 749 929 
All other HospitalVarious537 613 1,120 1,314 
Oncology$3,088 $3,145 $6,055 $6,007 
IbranceHR-positive/HER2-negative metastatic breast cancer1,320 1,404 2,557 2,657 
Xtandi alliance revenuesmCRPC, nmCRPC, mCSPC290 303 558 570 
InlytaAdvanced RCC274 257 508 486 
Zirabev(e)
Treatment of mCRC; unresectable, locally advanced, recurrent or metastatic NSCLC; recurrent glioblastoma; metastatic RCC; and persistent, recurrent or metastatic cervical cancer
138 129 286 215 
BosulifPhiladelphia chromosome–positive chronic myelogenous leukemia156 136 284 259 
XalkoriALK-positive and ROS1-positive advanced NSCLC118 120 244 255 
Ruxience(e)
Non-hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis
113 120 237 218 
Retacrit(e)
Anemia106 103 221 212 
SutentAdvanced and/or metastatic RCC, adjuvant RCC, refractory GIST (after disease progression on, or intolerance to, imatinib mesylate) and advanced pancreatic neuroendocrine tumor97 194 211 394 
Lorbrena
ALK-positive metastatic NSCLC
77 66 149 126 
Bavencio alliance revenuesLocally advanced or metastatic urothelial carcinoma; metastatic Merkel cell carcinoma; immunotherapy and tyrosine kinase inhibitor combination for patients with advanced RCC58 37 125 68 
AromasinPost-menopausal early and advanced breast cancer59 51 121 103 
BesponsaRelapsed or refractory B-cell acute lymphoblastic leukemia 58 45 109 95 
Braftovi
In combination with Mektovi for metastatic melanoma in patients with a BRAFV600E/K mutation and, in combination with Erbitux® (cetuximab)(f), for the treatment of BRAFV600E -mutant mCRC after prior therapy
51 42 98 89 
Trazimera(e)
HER-positive breast cancer and metastatic stomach cancers46 41 98 87 
Mektovi
In combination with Braftovi for metastatic melanoma in patients with a BRAFV600E/K mutation
44 36 84 71 
All other OncologyVarious82 60 163 102 
Internal Medicine$2,405 $2,403 $4,846 $4,997 
Eliquis alliance revenues and direct salesNonvalvular atrial fibrillation, deep vein thrombosis, pulmonary embolism1,745 1,481 3,537 3,124 
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(MILLIONS)Three Months EndedSix Months Ended
PRODUCTPRIMARY INDICATION OR CLASSJuly 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Premarin familySymptoms of menopause115 128 217 271 
BMP2Development of bone and cartilage75 66 142 115 
ToviazOveractive bladder45 62 99 119 
Chantix/ChampixAn aid to smoking cessation treatment in adults 18 years of age or older184 401 
All other Internal MedicineVarious424 482 846 966 
Rare Disease$909 $895 $1,872 $1,720 
Vyndaqel/VyndamaxATTR-cardiomyopathy and polyneuropathy552 501 1,164 953 
BeneFIXHemophilia B113 112 225 225 
GenotropinReplacement of human growth hormone91 109 171 189 
SomavertAcromegaly64 68 132 133 
Refacto AF/XynthaHemophilia A64 77 129 165 
All other Rare DiseaseVarious25 29 50 55 
Inflammation & Immunology (I&I)$850 $1,041 $1,671 $2,107 
Xeljanz
RA, PsA, UC, active polyarticular course juvenile idiopathic arthritis, ankylosing spondylitis
430 586 802 1,124 
Enbrel (Outside the U.S. and Canada)
RA, juvenile idiopathic arthritis, PsA, plaque psoriasis, pediatric plaque psoriasis, ankylosing spondylitis and nonradiographic axial spondyloarthritis
257 286 537 605 
Inflectra(e)
Crohn’s disease, pediatric Crohn’s disease, UC, pediatric UC, RA in combination with methotrexate, ankylosing spondylitis, PsA and plaque psoriasis
137 136 272 313 
All other I&IVarious25 33 60 65 
PFIZER CENTREONE(b)
$317 $437 $655 $827 
Total Alliance revenues$2,317 $1,880 $4,631 $3,650 
Total Biosimilars(e)
$580 $559 $1,185 $1,089 
Total Sterile Injectable Pharmaceuticals(g)
$1,286 $1,381 $2,617 $2,863 
(a)On December 31, 2021, we completed the sale of our Meridian subsidiary. Prior to its sale, Meridian was managed as part of the Hospital therapeutic area. Beginning in the fourth quarter of 2021, the financial results of Meridian were reflected as discontinued operations. Prior-period financial information has been restated, as appropriate. See Note 1A.
(b)At the beginning of our fiscal fourth quarter of 2021, we reorganized our commercial operations and began to manage our commercial operations through a new global structure consisting of two operating segments, each led by a single manager: Biopharma, our innovative science-based biopharmaceutical business, and PC1. PC1, which previously had been managed within the Hospital therapeutic area, includes revenues from our contract manufacturing, including certain Comirnaty-related manufacturing activities performed on behalf of BioNTech ($55 million and $101 million for the second quarter and the first six months of 2022, respectively, and $87 million for both the second quarter and the first six months of 2021), and revenues from our active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with former legacy Pfizer businesses/partnerships, including but not limited to, transitional manufacturing and supply agreements with Viatris following the spin-off of the Upjohn Business. We have revised prior-period information to conform to the current management structure.
(c)Prevnar family include revenues from Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20/Apexxnar (adult).
(d)Immunoglobulin (Ig) portfolio includes the revenues from Panzyga, Octagam and Cutaquig.
(e)Biosimilars are highly similar versions of approved and authorized biological medicines and primarily include revenues from Zirabev, Inflectra, Ruxience, Retacrit and Trazimera.
(f)Erbitux® is a registered trademark of ImClone LLC.
(g)Total Sterile Injectable Pharmaceuticals represents the total of all branded and generic injectable products in the Hospital therapeutic area, including anti-infective sterile injectable pharmaceuticals.

Remaining Performance Obligations––Contracted revenue expected to be recognized from remaining performance obligations for firm orders in long-term contracts to supply Comirnaty to our customers totaled approximately $24 billion as of July 3, 2022, which includes amounts received in advance and deferred, as well as amounts that will be invoiced as we deliver these products to our customers in future periods. Of this amount, we expect to recognize revenue of approximately $12 billion in 2022, $12 billion in 2023 and $200 million in 2024. Remaining performance obligations exclude arrangements with an original expected contract duration of less than one year.
Deferred Revenues––Our deferred revenues primarily relate to advance payments received or receivable from various government or government sponsored customers in international markets for supply of Comirnaty and Paxlovid. The deferred revenues related to Comirnaty and Paxlovid total $3.9 billion as of July 3, 2022, with $3.7 billion and $198 million recorded in current and noncurrent liabilities, respectively. The deferred revenues related to Comirnaty total $3.3 billion as of December 31, 2021, with $3.0 billion and $249 million recorded in current liabilities and noncurrent liabilities, respectively. There were no deferred revenues associated with Paxlovid as of December 31, 2021. The increase in Comirnaty and Paxlovid deferred revenues during the first six months of 2022 was primarily the result of additional advance payments received as we entered
35


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
into new or amended contracts, including new advance payments received for Paxlovid contracts, less amounts recognized in Revenues as we delivered the products to our customers and the impact of foreign exchange. During the second quarter and first six months of 2022, we recognized revenue of $800 million and $2.4 billion, respectively, that was included in the balance of Comirnaty deferred revenues as of December 31, 2021. The Comirnaty and Paxlovid deferred revenues as of July 3, 2022 will be recognized in Revenues proportionately as we transfer control of the products to our customers and satisfy our performance obligation under the contracts, with the amounts included in current liabilities expected to be recognized in Revenues within the next 12 months, and the amounts included in noncurrent liabilities expected to be recognized in Revenues in the last six months of 2023 and in the first quarter of 2024. Deferred revenues associated with contracts for other products were not significant as of July 3, 2022 or December 31, 2021.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
OVERVIEW OF OUR PERFORMANCE, OPERATING ENVIRONMENT, STRATEGY AND OUTLOOK
References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although foreign exchange rate changes are part of our business, they are not within our control and since they can mask positive or negative trends in the business, we believe presenting operational variances excluding these foreign exchange changes provides useful information to evaluate our results.
Our Business and Strategy
We apply science and our global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide. At the beginning of our fiscal fourth quarter of 2021, we reorganized our commercial operations and began to manage our commercial operations through a new global structure consisting of two operating segments: Biopharma and PC1. Biopharma is the only reportable segment. See Note 1A. We expect to incur costs of approximately $700 million in connection with separating Upjohn, of which approximately 80% has been incurred since inception and through the second quarter of 2022. These charges include costs and expenses related to separation of legal entities and transaction costs.
Beginning in our third fiscal quarter of 2022, we are making several additional organizational changes to further transform our operations. These changes include establishing a new commercial structure within Biopharma that is designed to better support Comirnaty and Paxlovid in a potential full commercial setting while optimizing our performance across three broad therapeutic areas:
Primary Care will consist of our COVID-19 products (currently Comirnaty and Paxlovid), as well as the Internal Medicine and Vaccines product portfolios, including potential future mRNA products.
Specialty Care will consist of our Inflammation & Immunology, Rare Disease and Hospital (excluding Paxlovid) product portfolios.
Oncology will consist of our Oncology product portfolio.
We are currently evaluating what impacts these organizational changes may have on our financial reporting.
For additional information about our business, strategy and operating environment, see the Item 1. Business section and Overview of Our Performance, Operating Environment, Strategy and Outlook section within MD&A of our 2021 Form 10-K.
Our Business Development Initiatives
We are committed to strategically capitalizing on growth opportunities, primarily by advancing our own product pipeline and maximizing the value of our existing products, but also through various business development activities.
Our significant recent business development activities include the transactions discussed in Note 2 and the following:
Acquisition of Global Blood Therapeutics, Inc. (GBT)––In August 2022, we and GBT announced that the companies entered into an agreement under which we will acquire GBT, a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities, starting with sickle cell disease. Under the terms of the agreement, we will acquire all outstanding shares of GBT for $68.50 per share in cash for a total enterprise value of approximately $5.4 billion, including debt and net of cash acquired. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals and approval by GBT’s stockholders.
Acquisition of ReViral––In June 2022, which falls in our international third quarter of 2022, we completed our acquisition of ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel antiviral therapeutics that target respiratory syncytial virus, for a total consideration of up to $525 million, including an upfront payment of $425 million upon closing and an additional $100 million contingent upon future development milestones.
Acquisition of Biohaven––In May 2022, we and Biohaven announced that the companies entered into an agreement under which we will acquire Biohaven, the maker of Nurtec® ODT (rimegepant), an innovative dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults. Under the terms of the agreement, we will acquire all outstanding common shares of Biohaven not already owned by us for $148.50 per share, in cash. The proposed transaction includes the acquisition of Biohaven’s CGRP programs, including rimegepant, zavegepant and a portfolio of five pre-clinical CGRP assets. Biohaven common shareholders, including Pfizer, will also receive 0.5 of a share of New Biohaven, a new publicly traded company that will retain Biohaven’s non-CGRP development stage pipeline compounds, per Biohaven common share. Pfizer will pay transaction consideration totaling approximately $11.6 billion in cash. Pfizer will also make payments at closing to settle Biohaven’s third party debt and for the redemption of all outstanding shares of Biohaven’s redeemable preferred stock.
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This agreement follows on the November 2021 collaboration for the commercialization of rimegepant and zavegepant outside the U.S., in connection with which Pfizer acquired 2.6% of Biohaven’s common stock. New Biohaven will also have the right to receive tiered royalties from Pfizer on any annual net sales of rimegepant and zavegepant in the U.S. in excess of $5.25 billion. The proposed transaction is subject to the completion of the New Biohaven spin-off transaction and other customary closing conditions. All required antitrust clearances have been received. The companies expect the transaction to close by early 2023.
For a description of the more significant recent transactions through February 24, 2022, the filing date of our 2021 Form 10-K, see Note 2 in our 2021 Form 10-K.
Our Second Quarter 2022 and First Six Months of 2022 Performance
Revenues––Revenues increased $8.8 billion, or 47%, in the second quarter of 2022 to $27.7 billion from $18.9 billion in the second quarter of 2021, reflecting an operational increase of $10.1 billion, or 53%, as well as an unfavorable impact of foreign exchange of $1.3 billion, or 7%. The operational increase was primarily driven by growth from Paxlovid and Comirnaty. Excluding the impact of Paxlovid and Comirnaty, revenues increased 1% operationally, reflecting strong growth in Eliquis, the Prevnar family and Vyndaqel/Vyndamax, partially offset by declines in Chantix/Champix, Xeljanz and Sutent.
Revenues increased $20.0 billion, or 60%, in the first six months of 2022 to $53.4 billion from $33.4 billion in the first six months of 2021, reflecting an operational increase of $22.0 billion, or 66%, as well as an unfavorable impact of foreign exchange of $2.0 billion, or 6%. The operational increase was primarily driven by growth from Comirnaty and Paxlovid. Excluding the impact of Comirnaty and Paxlovid, revenues increased 1% operationally, reflecting strong growth in Eliquis, the Prevnar family, Vyndaqel/Vyndamax and Biosimilars, partially offset by declines in Chantix/Champix, Xeljanz and Sutent.
See the Analysis of the Condensed Consolidated Statements of Income––Revenues by Geography and Revenues––Selected Product Discussion sections for more information, including a discussion of key drivers of our revenue performance. For information regarding the primary indications or class of certain products, see Note 13C.
Income from Continuing Operations Before Provision/(Benefit) for Taxes on Income––The increases in Income from continuing operations before provision/(benefit) for taxes on income of $4.5 billion in the second quarter of 2022 and $7.9 billion in the first six months of 2022, compared to the same periods in 2021, respectively, were primarily attributable to (i) higher revenues, partially offset by (ii) increases in Cost of sales, (iii) net losses on equity securities in the second quarter and first six months of 2022 versus net gains on equity securities in the second quarter and first six months of 2021, (iv) increases in Research and development expenses, (v) net periodic benefit costs associated with pension and other postretirement plans incurred in the second quarter and first six months of 2022 versus net periodic benefit credits recognized in the second quarter and first six months of 2021 and (vi) increases in Restructuring charges and certain acquisition-related costs.
See the Analysis of the Condensed Consolidated Statements of Income within MD&A and Note 4 for additional information.
For information on our tax provision and effective tax rate, see the Provision/(Benefit) for Taxes on Income section within MD&A and Note 5.
Our Operating Environment
We, like other businesses in our industry, are subject to certain industry-specific challenges. These include, among others, the topics listed below, as well as in the Item 1. Business––Government Regulation and Price Constraints and Item 1A. Risk Factors sections, and the Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Operating Environment section of the MD&A of our 2021 Form 10-K.
Intellectual Property Rights and Collaboration/Licensing Rights––The loss, expiration or invalidation of intellectual property rights, patent litigation settlements with manufacturers and the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues. Certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years, and we expect certain products to face increased generic competition over the next few years. While additional patent expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries from 2022 through 2025. We continue to vigorously defend our patent rights against infringement, and we will continue to support efforts that strengthen worldwide recognition of patent rights while taking necessary steps to help ensure appropriate patient access.
For additional information on patent rights we consider most significant in relation to our business as a whole, see the Item 1. Business––Patents and Other Intellectual Property Rights section of our 2021 Form 10-K. For a discussion of recent developments with respect to patent litigation, see Note 12A1.
Regulatory Environment/Pricing and Access––Government and Other Payer Group Pressures––Governments globally, as well as private third-party payers in the U.S., may use a variety of measures to control costs, including, among others, proposing
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pricing reform or legislation, employing formularies to control costs, cross country collaboration and procurement, price cuts, mandatory rebates, health technology assessments, forced localization as a condition of market access, “international reference pricing” (i.e., the practice of a country linking its regulated medicine prices to those of other countries), quality consistency evaluation processes and volume-based procurement. We anticipate that these and similar initiatives will continue to increase pricing and access pressures globally. In the U.S., we recently implemented a policy that will help improve contract pharmacy integrity. The U.S. Department of Health and Human Services (HHS) has sent letters to numerous manufacturers that have also implemented contract pharmacy integrity initiatives expressing the view that their programs are in violation of the 340B statute, and referring those programs for potential enforcement action. We believe that our program is consistent with the statute. Additional legal or legislative developments with respect to the 340B program may have an adverse impact on our integrity initiative, and we may face enforcement action or penalties, depending upon such developments. For additional information, see the Item 1. Business––Pricing Pressures and Managed Care Organizations and ––Government Regulation and Price Constraints sections in our 2021 Form 10-K and the Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Operating Environment section of the MD&A in our 2021 Form 10-K.
Product Supply––We periodically encounter supply delays, disruptions and shortages, including due to voluntary product recalls. In response to requests from various regulatory authorities, manufacturers across the pharmaceutical industry, including Pfizer, are evaluating their product portfolios for the potential presence or formation of nitrosamines. This has led to recalls, including our voluntary recall of Chantix in 2021 and additional voluntary recalls initiated for other products in 2022 due to the presence of nitrosamines above the applicable acceptable intake limit, and may lead to additional recalls or other market actions for Pfizer products. For information on our Chantix recall in 2021 and risks related to product manufacturing, see the Item 1A. Risk Factors––Product Manufacturing, Sales and Marketing Risks section of our 2021 Form 10-K.
The Global Economic Environment
In addition to the industry-specific factors discussed above, we, like other businesses of our size and global extent of activities, are exposed to economic cycles. For additional information, see the Overview of Our Performance, Operating Environment, Strategy and Outlook––The Global Economic Environment section of the MD&A of our 2021 Form 10-K.
Russia/Ukraine Conflict––Our global operations may be impacted by certain factors in the global economic environment including impacts of political or civil unrest or military action, including the armed conflict between Russia and Ukraine. Consistent with our commitment to putting patients first, we are maintaining the supply of medicines to Russia, including the provision of needed medicines to patients already enrolled in clinical trials. Effective March 14, 2022, Pfizer is donating the equivalent of profits of our Russian subsidiary to causes that provide direct humanitarian support to the people of Ukraine, in addition to the company’s ongoing efforts to support the humanitarian response in the region. Our first down payment of $5 million is going to eight global and local non-governmental organizations to support humanitarian relief and response efforts. We will continue to divert these profits to the Ukrainian relief efforts until peace is achieved. Additionally, we are not initiating new clinical trials in Russia, have stopped recruiting new patients in our ongoing clinical trials in the country, and halted all new investments with local suppliers intended to build manufacturing capacity in Russia. For both the six months ended July 3, 2022 and the fiscal year ended December 31, 2021, the business of our Russia and Ukraine subsidiaries represented less than 1% of our consolidated revenues and assets, and while we are monitoring the effects of the armed conflict between Russia and Ukraine, the situation continues to evolve and the long-term implications, including the broader economic consequences of the conflict, are difficult to predict at this time. While as of now, we do not anticipate any significant negative impacts on our business from this conflict, continued regional instability, geopolitical shifts, potential additional sanctions and other restrictive measures against Russia, neighboring countries or allies of Russia, and any retaliatory measures taken by Russia, neighboring countries or allies of Russia, in response to such measures could adversely affect the global macroeconomic environment, our operations, currency exchange rates and financial markets, which could in turn adversely impact our business and results of operations.

COVID-19 Pandemic––The COVID-19 pandemic has impacted our business, operations and financial condition and results.
Our Response to COVID-19
Pfizer is continuing to help lead the global effort to confront the COVID-19 pandemic by advancing a vision for industry-wide collaboration while continuing to make significant investments in breakthrough science and global manufacturing.
Comirnaty/BNT162b2:
We have collaborated with BioNTech to jointly develop Comirnaty/BNT162b2, a mRNA-based coronavirus vaccine to help prevent COVID-19. For additional information, see the Product Developments section of this MD&A. We continue to evaluate our vaccine and the short- and long-term safety and efficacy of Comirnaty. We are also studying monovalent, bivalent and variant-adapted vaccine candidates to potentially help prevent COVID-19 caused by variants of concern, as well as a next-generation mRNA vaccine candidate.
The companies have entered into agreements to supply pre-specified doses of Comirnaty in 2022 with multiple developed and emerging countries around the world and are continuing to deliver doses of Comirnaty to governments under such
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agreements. We also signed agreements with multiple countries to supply Comirnaty doses in 2023 and are currently negotiating similar potential agreements with multiple countries as well. Additionally, we will continue our efforts to help ensure equitable access to Comirnaty and anticipate delivering at least two billion doses to low- and middle-income countries—one billion of which were delivered in 2021 and approximately 460 million of which were delivered in the first half of 2022. Certain of the aforementioned doses to low- and middle-income countries are being supplied to the U.S. government at a not-for-profit price to be donated to the world’s poorest nations.
As of July 28, 2022, we forecasted approximately $32 billion of revenues for Comirnaty in 2022, with gross profit to be split evenly with BioNTech, which includes doses expected to be delivered in fiscal 2022, primarily under contracts signed as of mid-July 2022.
Paxlovid:
In December 2021, the FDA authorized the emergency use of Paxlovid, a novel oral COVID-19 treatment, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid has been granted an authorization or approval in many other countries. In June 2022, we submitted an NDA to the FDA for approval of Paxlovid for the treatment of COVID-19 in both vaccinated and unvaccinated individuals who are at high risk for progression to severe illness from COVID-19 consistent with the current EUA. For additional information, see the Product Developments section of this MD&A.
We continue to evaluate Paxlovid in other populations, including in non-hospitalized, symptomatic, pediatric patients with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease (Phase 2/3 study, EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients)). We also plan to study Paxlovid in those who are immunocompromised, hospitalized with severe COVID-19 and at increased risk for poor outcomes due to the disease, or who are pregnant. In June 2022, we announced that due to a very low rate of hospitalization or death observed in the standard-risk patient population, we ceased enrollment into the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study evaluating the use of Paxlovid in patients who are at standard risk for developing severe COVID-19. Pfizer had previously announced that the primary endpoint for EPIC-SR was not met.
We have entered into agreements to supply pre-specified courses of Paxlovid to multiple countries, such as the U.S. and U.K., as well as an agreement with UNICEF to supply low- and middle-income countries. Through the first half of 2022, we produced 30 million treatment courses, and we have capacity to meet the demand for Paxlovid in a flexible manner going forward.
As of July 28, 2022, we forecasted approximately $22 billion of revenues for Paxlovid in 2022, which includes treatment courses expected to be delivered in fiscal 2022, primarily relating to supply contracts signed or committed as of mid-July 2022.
Impact of COVID-19 on Our Business and Operations
As part of our on-going monitoring and assessment, we have made certain assumptions regarding the pandemic for purposes of our operational planning and financial projections, including assumptions regarding the duration, severity and the global macroeconomic impact of the pandemic, as well as COVID-19 vaccine and oral COVID-19 treatment revenues, supply and contracts, which remain dynamic. Despite careful tracking and planning, we are unable to accurately predict the extent of the impact of the pandemic on our business, operations and financial condition and results due to the uncertainty of future developments. We are focused on all aspects of our business and are implementing measures aimed at mitigating issues where possible, including by using digital technology to assist in operations for our commercial, manufacturing, R&D and corporate enabling functions globally.
As discussed in our 2021 Form 10-K, apart from our introduction of Comirnaty/BNT162b2 and Paxlovid, our business and operations were impacted by the pandemic in various ways; certain of those impacts have continued in 2022. For additional detail and discussion on the impact of the COVID-19 pandemic on certain of our products, sales and marketing, supply chain and clinical trials, see the Analysis of the Condensed Consolidated Statements of Income—Revenues by Geography and Revenues—Selected Product Discussion sections within this MD&A and the Overview of Our Performance, Operating Environment, Strategy and Outlook—The Global Economic Environment—COVID-19 Pandemic section of the MD&A of our 2021 Form 10-K.
We will continue to pursue efforts to maintain the continuity of our operations while monitoring for new developments related to the pandemic. Future developments could result in additional favorable or unfavorable impacts on our business, operations or financial condition and results. If we experience significant disruption in our manufacturing or supply chains or significant disruptions in clinical trials or other operations, if demand for our products is significantly reduced as a result of the COVID-19 pandemic, or if demand for our COVID-19 vaccine or oral COVID-19 treatment is reduced or no longer exists, we could experience a material adverse impact on our business, operations and financial condition and results.
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For additional information, see the Item 1A. Risk Factors—COVID-19 Pandemic section and the Overview of Our Performance, Operating Environment, Strategy and Outlook section of the MD&A of our 2021 Form 10-K.
SIGNIFICANT ACCOUNTING POLICIES AND APPLICATION OF CRITICAL ACCOUNTING ESTIMATES AND ASSUMPTIONS
For a description of our significant accounting policies, see Note 1 in our 2021 Form 10-K. Of these policies, the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and the most complex judgments: Acquisitions (Note 1E); Fair Value (Note 1F); Revenues (Note 1H); Asset Impairments (Note 1M); Tax Assets and Liabilities and Income Tax Contingencies (Note 1Q); Pension and Postretirement Benefit Plans (Note 1R); and Legal and Environmental Contingencies (Note 1S).
For a discussion about the critical accounting estimates and assumptions impacting our consolidated financial statements, see the Significant Accounting Policies and Application of Critical Accounting Estimates and Assumptions section within MD&A in our 2021 Form 10-K. See also Note 1D in our 2021 Form 10-K for a discussion about the risks associated with estimates and assumptions.
For a discussion of a recently adopted accounting standard, see Note 1B. For a discussion of presentation changes for Acquired in-process research and development expenses, see Note 1D.
ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF INCOME
Revenues by Geography
The following presents worldwide revenues by geography:
Three Months Ended
 WorldwideU.S.InternationalWorld-wideU.S.Inter-national
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
% Change in Revenues
Operating segments:
Biopharma$27,425 $18,463 $11,136 $7,380 $16,289 $11,083 49 51 47 
Pfizer CentreOne317 437 86 136 230 301 (27)(36)(23)
Total revenues$27,742 $18,899 $11,222 $7,515 $16,519 $11,384 47 49 45 
Six Months Ended
WorldwideU.S.InternationalWorld-wideU.S.Inter-national
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
% Change in Revenues
Operating segments:
Biopharma$52,748 $32,588 $19,952 $14,757 $32,795 $17,830 62 35 84 
Pfizer CentreOne655 827 188 288 467 539 (21)(35)(13)
Total revenues$53,402 $33,415 $20,140 $15,046 $33,262 $18,369 60 34 81 
41


Second Quarter of 2022 vs. Second Quarter of 2021
The following provides an analysis of the change in worldwide revenues by geographic areas in the second quarter of 2022:
Three Months Ended July 3, 2022
(MILLIONS)WorldwideU.S.International
Operational growth/(decline):
Worldwide growth from Paxlovid, Comirnaty, Eliquis, Prevnar family, Vyndaqel/Vyndamax, Inlyta and Biosimilars, partially offset by worldwide declines from Xeljanz, Ibrance and Xtandi. See the Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion within MD&A for additional analysis
$10,486 $3,972 $6,514 
Decline from PC1. See the Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion within MD&A for additional analysis
(109)(49)(60)
Lower revenues for Chantix/Champix and Sutent:
The decrease in Chantix/Champix was driven by the ongoing global pause in shipments of Chantix due to the presence of N-nitroso-varenicline above an acceptable level of intake set by various global regulators, the ultimate timing for resolution of which may vary by country
The decrease for Sutent primarily reflects lower volume demand in the U.S. and Europe following its loss of exclusivity in August 2021 and January 2022, respectively
(273)(177)(97)
Other operational factors, net(1)(39)37 
Operational growth, net10,103 3,707 6,395 
Unfavorable impact of foreign exchange(1,260)— (1,260)
Revenues increase/(decrease)
$8,842 $3,707 $5,135 
Emerging markets revenues increased $2.2 billion, or 58%, in the second quarter of 2022 to $6.0 billion from $3.8 billion in the second quarter of 2021, reflecting an operational increase of $2.4 billion, or 63%, and an unfavorable impact from foreign exchange of approximately 6%. The operational increase in emerging markets was primarily driven by growth from Comirnaty and Paxlovid.
First Six Months of 2022 vs. First Six Months of 2021
The following provides an analysis of the worldwide change in revenues by geographic areas in the first six months of 2022:
Six Months Ended July 3, 2022
(MILLIONS)WorldwideU.S.International
Operational growth/(decline):
Worldwide growth from Comirnaty, Paxlovid, Eliquis, Prevnar family, Vyndaqel/Vyndamax, Inlyta and Biosimilars, partially offset by worldwide declines from Xeljanz, Ibrance and Xtandi. See the Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion within MD&A for additional analysis
$22,854 $5,736 $17,117 
Decline from PC1. See the Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion within MD&A for additional analysis
(152)(100)(52)
Lower revenues for Chantix/Champix and Sutent:
The decrease in Chantix/Champix was driven by the ongoing global pause in shipments of Chantix due to the presence of N-nitroso-varenicline above an acceptable level of intake set by various global regulators, the ultimate timing for resolution of which may vary by country
The decrease for Sutent primarily reflects lower volume demand in the U.S. and Europe following its loss of exclusivity in August 2021 and January 2022, respectively
(568)(381)(187)
Other operational factors, net(108)(160)53 
Operational growth/(decline), net22,026 5,094 16,931 
Unfavorable impact of foreign exchange(2,038)— (2,038)
Revenues increase/(decrease)
$19,988 $5,094 $14,893 
Emerging markets revenues increased $6.7 billion, or 102%, in the first six months of 2022 to $13.4 billion from $6.6 billion in the first six months of 2021, reflecting an operational increase of $7.2 billion, or 108%, and an unfavorable impact from foreign exchange of approximately 7%. The operational increase in emerging markets was primarily driven by growth from Comirnaty and Paxlovid.
42


Revenue Deductions––Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. These deductions represent estimates of related obligations and, as such, knowledge and judgment are required when estimating the impact of these revenue deductions on gross sales for a reporting period. Historically, adjustments to these estimates to reflect actual results or updated expectations, have not been material to our overall business and generally have been less than 1% of revenues. Product-specific rebates, however, can have a significant impact on year-over-year individual product revenue growth trends.
The following presents information about revenue deductions:
 Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
July 3,
2022
July 4,
2021
Medicare rebates$186 $182 $387 $371 
Medicaid and related state program rebates225 306 466 652 
Performance-based contract rebates862 788 1,667 1,541 
Chargebacks1,797 1,518 3,534 2,949 
Sales allowances1,367 1,211 2,571 2,354 
Sales returns and cash discounts328 235 598 459 
Total$4,765 $4,240 $9,223 $8,326 
Revenue deductions are primarily a function of product sales volume, mix of products sold, contractual or legislative discounts and rebates.
For information on our accruals for revenue deductions, including the balance sheet classification of these accruals, see Note 1C.
43


Revenues––Selected Product Discussion
Biopharma
(MILLIONS)Revenue% Change
ProductPeriodGlobal
Revenues
RegionJuly 3, 2022July 4, 2021TotalOper.Operational Results Commentary
Comirnaty(a)
QTD
$8,848

Up 20%

(operationally)
U.S.$1,080 $2,034 (47)
Driven by strong operational growth in international markets, led by increased sales of doses to serve emerging markets and increased deliveries to certain international developed markets, partially offset by a slower pace of deliveries to the U.S. and Canada.
Int’l.7,768 5,804 34 43 
Worldwide$8,848 $7,838 13 20 
YTD
$22,075

* (operationally)
U.S.$3,395 $4,072 (17)
Int’l.18,681 7,228 **
Worldwide$22,075 $11,300 95 *
PaxlovidQTD
$8,115

 *

U.S.$4,455 $— *
Driven by the U.S. launch under emergency use authorization in December 2021 and international launches in late 2021 and early 2022 following regulatory approvals or emergency use authorizations.
Int’l.3,660 — **
Worldwide$8,115 $— **
YTD
$9,585

*

U.S.$5,470 $— *
Int’l.4,115 — **
Worldwide$9,585 $— **
EliquisQTD
$1,745

Up 23%

(operationally)
U.S.$1,064 $831 28 
Global growth driven primarily by continued oral anti-coagulant adoption and market share gains in non-valvular atrial fibrillation, particularly in the U.S. and certain markets in Europe, as well as favorable changes in channel mix in the U.S.

In addition, YTD performance was negatively impacted by the non-recurrence of an $80 million favorable adjustment related to the Medicare “coverage gap” provision recorded in the first quarter of 2021.
Int’l.681 650 16 
Worldwide$1,745 $1,481 18 23 
YTD
$3,537

Up 17%

(operationally)
U.S.$2,144 $1,812 18 
Int’l.1,394 1,312 15 
Worldwide$3,537 $3,124 13 17 
Prevnar familyQTD
$1,429

Up 18%

(operationally)
U.S.$906 $642 41 
Growth primarily driven by the adult indications in the U.S. due to strong stocking and patient demand following the launch of Prevnar 20 for the adult population, partially offset by unfavorable timing of government and private purchasing of Prevnar 13 for the pediatric indication globally.

In addition, YTD international performance was negatively impacted by competitive pressures in China for the pediatric indication and timing of government purchasing for the adult indication.
Int’l.523 599 (13)(7)
Worldwide$1,429 $1,241 15 18 
YTD
$2,994

Up 21%

(operationally)
U.S.$1,920 $1,280 50 
Int’l.1,074 1,244 (14)(10)
Worldwide$2,994 $2,524 19 21 
IbranceQTD
$1,320

Down 3%
 
(operationally)
U.S.$868 $862 
QTD decline primarily driven by prior-year quarter clinical trial purchases in international developed markets, partially offset by modest growth in the U.S. despite continued increase in the proportion of patients accessing Ibrance through the Patient Assistance Program.

YTD decline largely due to a continued increase in the proportion of patients accessing Ibrance through the U.S. Patient Assistance Program and prior-year quarter clinical trial purchases in international developed markets, partially offset by higher volumes in emerging markets.
Int’l.452 542 (17)(8)
Worldwide$1,320 $1,404 (6)(3)
YTD
$2,557

Down 1%

(operationally)
U.S.$1,621 $1,656 (2)
Int’l.936 1,002 (7)
Worldwide$2,557 $2,657 (4)(1)
Vyndaqel/
Vyndamax
QTD
$552

Up 16%

(operationally)
U.S.$296 $225 32 Growth largely driven by continued strong uptake of the ATTR-CM indication, primarily in developed Europe and the U.S., partially offset by a planned price decrease which recently went into effect in Japan.
Int’l.256 276 (7)
Worldwide$552 $501 10 16 
YTD
$1,164

Up 28%

(operationally)
U.S.$561 $430 30 
Int’l.603 523 15 26 
Worldwide$1,164 $953 22 28 
XeljanzQTD
$430

Down 24%

(operationally)
U.S.$254 $390 (35)
Driven primarily by declines in net price due to unfavorable changes in channel mix, decreased prescription volumes globally resulting from ongoing shifts in prescribing patterns related to JAK class label changes, and unfavorable wholesaler inventory buying patterns in the U.S.
Int’l.176 195 (10)(2)
Worldwide$430 $586 (27)(24)
YTD
$802

Down 26%

(operationally)
U.S.$457 $722 (37)
Int’l.345 402 (14)(8)
Worldwide$802 $1,124 (29)(26)
44


(MILLIONS)Revenue% Change
ProductPeriodGlobal
Revenues
RegionJuly 3, 2022July 4, 2021TotalOper.Operational Results Commentary
XtandiQTD
$290

Down 4%

(operationally)
U.S.$290 $303 (4)
Decline largely due to channel mix and fluctuating enrollment rates in the Xtandi Patient Assistance Program, partially offset by recent demand growth and an increase in new patient starts across the mCRPC, nmCRPC, and mCSPC indications.
Int’l.— — 
Worldwide$290 $303 (4)(4)
YTD
$558

Down 2%

(operationally)
U.S.$558 $570 (2)
Int’l.— — 
Worldwide$558 $570 (2)(2)
InlytaQTD
$274

Up 11%

(operationally)
U.S.$162 $155 
Growth primarily reflects continued adoption in emerging markets and developed Europe of combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced RCC.
Int’l.112 102 20 
Worldwide$274 $257 11 
YTD
$508

Up 8%

(operationally)
U.S.$302 $296 
Int’l.206 190 17 
Worldwide$508 $486 
BiosimilarsQTD
$580

Up 7%

(operationally)
U.S.$401 $363 10 
Growth mainly driven by oncology biosimilars primarily due to strong U.S. growth of Zirabev and Retacrit.

In addition, YTD performance was negatively impacted by decreases in Inflectra globally as a result of competitive pressures for certain biosimilars.
Int’l.179 195 (8)(1)
Worldwide$580 $559 
YTD
$1,185

Up 11%

(operationally)
U.S.$837 $691 21 
Int’l.348 398 (13)(6)
Worldwide$1,185 $1,089 11 
Pfizer CentreOne
(MILLIONS)Revenue% Change
Operating SegmentPeriodGlobal
Revenues
RegionJuly 3, 2022July 4, 2021TotalOper.Operational Results Commentary
PC1QTD
$317

Down 25%

(operationally)
U.S.$86 $136 (36)
Decline primarily driven by lower manufacturing of divested products under manufacturing and supply agreements and lower COVID-19 manufacturing activities performed on behalf of customers, including, with respect to the second quarter, Comirnaty supply to BioNTech.
Int’l.230 301 (23)(20)
Worldwide$317 $437 (27)(25)
YTD
$655

Down 18%

(operationally)
U.S.$188 $288 (35)
Int’l.467 539 (13)(10)
Worldwide$655 $827 (21)(18)
(a)Comirnaty includes direct sales and alliance revenues related to sales of the Pfizer-BioNTech COVID-19 vaccine, which are recorded within our Vaccines therapeutic area. It does not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in the PC1 contract development and manufacturing operation. Revenues related to these manufacturing activities totaled $55 million and $101 million for the second quarter and the first six months of 2022, respectively, and $87 million for both the second quarter and the first six months of 2021.
*    Indicates calculation not meaningful.
See the Item 1. BusinessPatents and Other Intellectual Property Rights section of our 2021 Form 10-K for information regarding the expiration of various patent rights, Note 12 for a discussion of recent developments concerning patent and product litigation relating to certain of the products discussed above, and Note 13C for information regarding the primary indications or class of the selected products discussed.
Product Developments
A comprehensive update of Pfizer’s development pipeline was published as of July 28, 2022 and is available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of our research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
The following provides information as of the date of this filing about significant marketing application-related regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan.
The table below includes only approvals for products that have occurred in the last twelve months and generally does not include approvals that may have occurred prior to that time. The table includes filings with regulatory decisions pending (even if the filing occurred outside of the last twelve-month period).
45


PRODUCTDISEASE AREAAPPROVED/FILED*
U.S.EUJAPAN
Comirnaty/BNT162b2
(PF-07302048)(a)
Immunization to prevent COVID-19 (16 years of age and older)
BLA
Aug.
2021
CMA
Dec.
2020
Approved
Feb.
2021
Immunization to prevent COVID-19 (12-15 years of age)
sBLA
July
2022
CMA
May
2021
Approved
May
2021
Immunization to prevent COVID-19 (booster)
EUA
Sep.
2021
CMA
Oct.
2021
Approved
Nov.
2021
Immunization to prevent COVID-19 (5-11 years of age)
EUA
Oct.
2021
CMA
Nov.
2021
Approved
Jan.
2022
Immunization to prevent COVID-19 (6 months through 4 years of age)
EUA
June
2022
Filed
July
2022
Filed
July
2022
Cibinqo
(abrocitinib)
Atopic dermatitis
Approved
Jan.
2022
Approved
Dec.
2021
Approved
Sep.
2021
Xeljanz
(tofacitinib)
Ankylosing spondylitis
Approved
Dec.
2021
Approved
Nov.
2021
Myfembree
(relugolix fixed dose combination)(b)
Uterine fibroids (combination with estradiol and norethindrone acetate)
Approved
May
2021
Endometriosis (combination with estradiol and norethindrone acetate)
Approved
Aug.
2022
Lorbrena/Lorviqua
(lorlatinib)
First-line ALK-positive NSCLC
Approved
Mar.
2021
Approved
Jan.
2022
Approved
Nov.
2021
Ngenla
(somatrogon)(c)
Pediatric growth hormone deficiency
Filed
Jan.
2021
Approved
Feb.
2022
Approved
Jan.
2022
Prevnar 20/Apexxnar
(Vaccine)(d)
Immunization to prevent invasive and non-invasive pneumococcal infections (adults)
Approved
June
2021
Approved
Feb.
2022
TicoVac
(Vaccine)
Immunization to prevent tick-borne encephalitis
Approved
Aug.
2021
Paxlovid(e) (nirmatrelvir [PF-07321332]; ritonavir)
COVID-19 infection (high risk population)
EUA
Dec.
2021
CMA
Jan.
2022
Approved
Feb.
2022
Vydura
(rimegepant)(f)
Acute migraine
Approved
Apr.
2022
Migraine prevention
Approved
Apr.
2022
*For the U.S., the filing date is the date on which the FDA accepted our submission. For the EU, the filing date is the date on which the EMA validated our submission.
(a)Being developed in collaboration with BioNTech. Comirnaty/BNT162b2 is approved by the FDA for individuals 12 years and older (30-µg, 2-dose primary series) and is FDA authorized to provide: (i) a 3-µg, 3-dose primary series to individuals 6 months through 4 years of age, (ii) a 10-µg, 2-dose primary series to individuals 5-11 years of age, (iii) a third 10-µg primary series dose to individuals 5-11 years of age with certain kinds of immunocompromise, (iv) a 30-µg, 2-dose primary series to individuals 12 years of age and older, (iv) a third 30-µg primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, (v) a single 10-µg booster dose to individuals 5-11 years of age who have completed a primary series with Comirnaty/BNT162b2, (vi) a 30-µg, first booster dose to individuals 12 years of age and older who have completed a primary series with Comirnaty/BNT162b2, (vii) a 30-µg, first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine (booster schedule based on labeling information of vaccine used for primary series), (viii) a 30-µg, second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine and (ix) a 30-µg, second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine. Comirnaty/BNT162b2 has been granted CMA by the EC to prevent COVID-19 in people aged 5 years and older. The vaccine is administered as a 2-dose series, 3 weeks apart. Adults and adolescents from the age of 12 are given 30-µg per dose; children aged 5 to 11 years are given 10-µg per dose. In addition, the CMA has been expanded to include a booster dose (third dose) at least 3 months after the second dose in individuals 12 years of age and older. A third primary course dose may be administered at least 28 days after the second dose to people aged 5 years and older with a severely weakened immune system. In July 2022, Pfizer and BioNTech completed a submission to the EMA for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older. In Japan, Comirnaty/BNT162b2 has been granted exceptional approval by the Ministry of Health, Labour and Welfare to prevent infections caused by SARS-CoV-2 in people aged 5 years and older. The vaccine is administered as a 2-dose series, 3 weeks apart. Adults and adolescents from the age of 12 are given 30-µg per dose; children aged 5 to 11 years are given 10-µg per dose. In addition, the exceptional approval has been expanded to include a booster dose (third dose) at least 5 months after the second dose in individuals 12 years of age and older.
(b)Being developed in collaboration with Myovant. In June 2022, the FDA accepted for review a sNDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) proposing updates to Myfembree’s U.S. Prescribing Information based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years. The PDUFA goal date for this sNDA is January 29, 2023.
(c)Being developed in collaboration with OPKO. In January 2022, Pfizer and OPKO received a Complete Response Letter (CRL) from the FDA for the BLA for somatrogon. Discussions are ongoing with the FDA regarding the CRL and how to best address their concerns.
46


(d)In October 2021, the CDC’s ACIP voted to recommend Prevnar 20 for routine use in adults. Specifically, the ACIP voted to recommend the following: (i) adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either pneumococcal 20-valent conjugate vaccine (PCV20) or pneumococcal 15-valent conjugate vaccine (PCV15)). If PCV15 is used, this should be followed by a dose of pneumococcal polysaccharide vaccine (PPSV23); and (ii) adults aged 19 years of age or older with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this should be followed by a dose of PPSV23. The recommendations were published in the Morbidity and Mortality Weekly Report on January 28, 2022. The publication also notes “for adults who have received pneumococcal conjugate vaccine (PCV13) but have not completed their recommended pneumococcal vaccine series with PPSV23, one dose of Prevnar 20 may be used if PPSV23 is not available.”
(e)In January 2022, the EMA approved the CMA of Paxlovid for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. In June 2022, we announced the submission of an NDA to the FDA for approval of Paxlovid for the treatment of COVID-19 in both vaccinated and unvaccinated individuals who are at high risk for progression to severe illness from COVID-19.
(f)Under a commercialization arrangement with Biohaven.
In December 2021, in light of the results from the completed required postmarketing safety study of Xeljanz, ORAL Surveillance (A3921133), the U.S. label for Xeljanz was revised. In addition, at the request of the EC, the PRAC of the EMA has adopted a referral procedure under Article 20 of Regulation (EC) No 726/2004 to assess safety information relating to oral JAK inhibitors authorized for inflammatory diseases, including Xeljanz and Cibinqo, which is ongoing. For additional information, see Item 1A. Risk Factors—Post-Authorization/Approval Data and the Product Development sections of our 2021 Form 10-K.
In China, the following products received regulatory approvals in the last twelve months: Cresemba for fungal infection and Besponsa for second line acute lymphoblastic leukemia, both in December 2021; Paxlovid for COVID-19 infection in February 2022; Cibinqo for atopic dermatitis in April 2022; Lorbrena for non-small cell lung cancer (first line and second line therapy) in April 2022.
The following provides information about additional indications and new drug candidates in late-stage development:
LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS
FOR IN-LINE AND IN-REGISTRATION PRODUCTS
PRODUCT/CANDIDATEPROPOSED DISEASE AREA
Ibrance (palbociclib)(a)
ER+/HER2+ metastatic breast cancer
Xtandi (enzalutamide)(b)
Non-metastatic high-risk castration sensitive prostate cancer
Talzenna (talazoparib)
Combination with Xtandi (enzalutamide) for first-line mCRPC
Combination with Xtandi (enzalutamide) for DNA Damage Repair (DDR)-deficient mCSPC
PF-06482077 (Vaccine)Immunization to prevent invasive and non-invasive pneumococcal infections (pediatric)
somatrogon (PF-06836922)(c)
Adult growth hormone deficiency
Braftovi (encorafenib) and Erbitux® (cetuximab)(d)
First-line BRAFv600E-mutant mCRC
Myfembree
(relugolix fixed dose combination)(e)
Combination with estradiol and norethindrone acetate for contraceptive efficacy
Braftovi (encorafenib) and Mektovi (binimetinib) and Keytruda® (pembrolizumab)(f)
BRAFv600E-mutant metastatic or unresectable locally advanced melanoma
Paxlovid (nirmatrelvir [PF-07321332]; ritonavir)
COVID-19 infection (pediatric)
NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENTaztreonam-avibactam
(PF-06947387)
Treatment of infections caused by Gram-negative bacteria
fidanacogene elaparvovec (PF-06838435)(g)
Hemophilia B
giroctocogene fitelparvovec
(PF-07055480)(h)
Hemophilia A
PF-06425090 (Vaccine)(i)
Immunization to prevent primary clostridioides difficile infection
PF-06886992 (Vaccine)Immunization to prevent serogroups meningococcal infection (adolescent and young adults)
PF-06928316 (Vaccine)Immunization to prevent respiratory syncytial virus infection (maternal)
Immunization to prevent respiratory syncytial virus infection (older adults)
ritlecitinib (PF-06651600)Alopecia areata
sasanlimab (PF-06801591)Combination with Bacillus Calmette-Guerin for non-muscle-invasive bladder cancer
fordadistrogene movaparvovec (PF-06939926)Duchenne muscular dystrophy
marstacimab (PF-06741086)Hemophilia
elranatamab (PF-06863135)(j)
Multiple myeloma triple-class refractory
Multiple myeloma double-class exposed
Newly diagnosed multiple myeloma
Omicron-based mRNA vaccine(k)
Immunization to prevent COVID-19 (adults)
Etrasimod (PF-07915503)Ulcerative colitis (moderately to severely active)
VLA15 (PF-07307405)(l)
Immunization to prevent Lyme Disease
(a)Being developed in collaboration with The Alliance Foundation Trials, LLC.
47


(b)Being developed in collaboration with Astellas.
(c)Being developed in collaboration with OPKO.
(d)Erbitux® is a registered trademark of ImClone LLC. In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono Pharmaceutical Co., Ltd.
(e)Being developed in collaboration with Myovant.
(f)Keytruda® is a registered trademark of Merck Sharp & Dohme Corp. In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono Pharmaceutical Co., Ltd.
(g)Being developed in collaboration with Spark Therapeutics, Inc.
(h)Being developed in collaboration with Sangamo Therapeutics, Inc.
(i)In March 2022, Pfizer announced results from the CLOVER trial (Clostridium difficile Vaccine Efficacy Trial), a pivotal Phase 3 study evaluating its Clostridioides difficile (C. difficile) vaccine candidate (PF-06425090) in the prevention of C. difficile infection (CDI). Initial analyses of two protocol defined secondary endpoints indicated a favorable benefit in reducing CDI severity and 100% vaccine efficacy in preventing medically attended CDI, although the trial did not meet its pre-specified primary endpoint of prevention of primary CDI. Safety reviews indicated that the investigational vaccine was safe and well tolerated. Pfizer is evaluating next steps for the program in coordination with regulatory agencies.
(j)Multiple myeloma triple-class refractory is currently in a Phase 2 registration-enabling study.
(k)Being developed in collaboration with BioNTech.
(l)Being developed in collaboration with Valneva SE.

In April 2022, Pfizer shared top-line results from the Paxlovid Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study in adults living in the same household as someone with a confirmed COVID-19 infection observing a risk reduction of 32% and 37% in adults who received Paxlovid for five and ten days, respectively, to prevent infection. These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met. In June 2022, an updated analysis from 1,153 patients enrolled in Paxlovid EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard Risk Patients) through December 2021 showed a non-significant 51% relative risk reduction (secondary endpoint, treatment arm: 5/576; placebo: 10/569). The primary endpoint in the EPIC-SR study also was not met. A sub-group analysis of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a non-significant 57% relative risk reduction in hospitalization or death (treatment arm: 3/361; placebo: 7/360). Additional analyses of secondary endpoint data showed that treatment with Paxlovid resulted in a nominally significant 62% decrease in COVID-19-related medical visits per day across all patients, relative to placebo (p=0.0228). Types of medical visits included trips to the emergency room, urgent care, hospital admissions, and telehealth calls, among others. An additional pre-specified descriptive analysis showed a 72% reduction in the average number of days in hospital among Paxlovid-treated patients versus placebo in EPIC-SR. Other not statistically significant findings included no Paxlovid-treated patients admitted to the intensive care unit, compared to three in the placebo group, and no deaths in patients who received Paxlovid with one death in the placebo group. Due to a very low rate of hospitalization or death observed in the standard-risk patient population, Pfizer decided to cease enrollment into EPIC-SR and include available data in the NDA submission to the FDA to support the use of Paxlovid in appropriate individuals at high risk of progression to severe illness. For additional information on Paxlovid, please see the COVID-19 Pandemic section of this MD&A.
In August 2022, we announced that an interim futility analysis of the global Phase 3 trial, REALM-DCM, designed to evaluate the efficacy and safety of PF-07265803 in patients with symptomatic dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA), indicated the trial is unlikely to meet its primary endpoint upon completion. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. This decision is not based on safety concerns.
For additional information about our R&D organization, see the Item 1. BusinessResearch and Development section of our 2021 Form 10-K.
COSTS AND EXPENSES
Costs and expenses follow:
Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
%
 Change
July 3,
2022
July 4,
2021
%
 Change
Cost of sales$8,648 $6,996 24 $18,632 $11,153 67 
Percentage of Revenues
31.2 %37.0 %34.9 %33.4 %
Selling, informational and administrative expenses3,048 2,923 5,642 5,700 (1)
Research and development expenses2,815 2,239 26 5,116 4,233 21 
Acquired in-process research and development expenses219 (100)356 238 50 
Amortization of intangible assets822 917 (10)1,657 1,776 (7)
Restructuring charges and certain acquisition-related costs189 (1)*381 21 *
Other (income)/deductions—net772 (1,343)*1,122 (2,347)*
* Indicates calculation not meaningful.
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Cost of Sales
Cost of sales increased $1.7 billion in the second quarter and $7.5 billion in the first six months of 2022, primarily due to:
the impact of Comirnaty, which includes a charge for the 50% gross profit split with BioNTech and applicable royalty expenses;
the impact of Paxlovid; and
a $450 million write-off of inventory related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used,
partially offset by:
the favorable impact of foreign exchange rates.
The decrease in Cost of sales as a percentage of revenues in the second quarter of 2022 was primarily due to favorable changes in sales mix, including significant sales of Paxlovid, as well as the favorable impact of foreign exchange rates, and an increase in alliance revenues, which have no associated cost of sales, partially offset by the impact of Comirnaty and the inventory write-offs related to COVID-19 products as discussed above.
The increase in Cost of sales as a percentage of revenues in the first six months of 2022 was primarily due to the impact of Comirnaty and the inventory write-off related to COVID-19 products as discussed above, partially offset by favorable changes in sales mix, including significant sales of Paxlovid, as well as the favorable impact of foreign exchange rates, and an increase in alliance revenues, which have no associated cost of sales.
Selling, Informational and Administrative (SI&A) Expenses
SI&A expenses increased $125 million in the second quarter of 2022, mostly due to:
increased spending on Paxlovid and Comirnaty and a higher provision for healthcare reform fees based on sales of Paxlovid and Comirnaty,
partially offset by:
a decrease in our liability to be paid to participants of our supplemental savings plan.
SI&A expenses decreased $59 million in the first six months of 2022, mainly due to:
a decrease in our liability to be paid to participants of our supplemental savings plan;
the favorable impact of foreign exchange; and
lower spending across the Inflammation & Immunology and Internal Medicine therapeutic areas,
partially offset by:
increased spending on Paxlovid and Comirnaty and a higher provision for healthcare reform fees based on sales of Paxlovid and Comirnaty.
Research and Development (R&D) Expenses
R&D expenses increased $576 million in the second quarter and $883 million in the first six months of 2022, primarily driven by increased investments across multiple late-stage clinical programs, including development costs and at-risk manufacturing related to programs to prevent and treat COVID-19, as well as costs to develop recently acquired assets.
Acquired In-Process Research and Development (IPR&D) Expenses
Acquired IPR&D expenses decreased $218 million in the second quarter of 2022, primarily reflecting the acquisition of Amplyx Pharmaceuticals Inc. (Amplyx) in the second quarter of 2021, and no transactions giving rise to acquired IPR&D expenses in the second quarter of 2022.
Acquired IPR&D expenses increased $118 million in the first six months of 2022, largely due to:
an upfront payment to Biohaven and a premium paid on our equity investment in Biohaven; and
a premium paid on our equity investment in BioNTech to develop a potential mRNA vaccine against shingles,
partially offset by:
the acquisition of Amplyx in the second quarter of 2021.
Amortization of Intangible Assets
Amortization of intangible assets decreased $95 million in the second quarter and $119 million in the first six months of 2022, primarily as a result of lower amortization of Comirnaty sales milestones to BioNTech.
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Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
Transforming to a More Focused Company Program––For a description of our program, as well as the anticipated and actual costs, see Note 3. The program savings discussed below may be rounded and represent approximations. In connection with restructuring our corporate enabling functions, we expect gross cost savings of $1.0 billion, or net cost savings, excluding merit and inflation growth and certain real estate cost increases, of $700 million, to be achieved primarily from 2021 through 2022. In connection with transforming our marketing strategy, we expect net cost savings of $1.4 billion, to be achieved primarily from 2022 through 2024. In connection with manufacturing network optimization, we expect net cost savings of $550 million to be achieved primarily from 2020 through 2023.
Certain qualifying costs for this program were recorded in the first two quarters of 2022 and 2021 and are reflected as Certain Significant Items and excluded from our non-GAAP measure of Adjusted Income. See the Non-GAAP Financial Measure: Adjusted Income section of this MD&A.
In addition to this program, we continuously monitor our operations for cost reduction and/or productivity opportunities, especially in light of the losses of exclusivity and the expiration of collaborative arrangements for various products.
Other (Income)/Deductions—Net
The period-over-period changes were primarily driven by:
net losses on equity securities in the second quarter and first six months of 2022 versus net gains recognized in the second quarter and first six months of 2021; and
net periodic benefit costs recorded in the second quarter and first six months of 2022 versus net periodic benefit credits recorded in the second quarter and first six months of 2021.
See Note 4 for additional information.
PROVISION/(BENEFIT) FOR TAXES ON INCOME
 Three Months EndedSix Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
%
Change
July 3,
2022
July 4,
2021
%
Change
Provision/(benefit) for taxes on income$1,570 $1,123 40 $2,742 $1,931 42 
Effective tax rate on continuing operations13.7 %16.2 %13.4 %15.3 % 
For information about our effective tax rate and the events and circumstances contributing to the changes between periods, as well as details about discrete elements that impacted our tax provisions, see Note 5.
DISCONTINUED OPERATIONS
For information about our discontinued operations, see Note 2B.
NON-GAAP FINANCIAL MEASURE: ADJUSTED INCOME
Adjusted income is an alternative measure of performance used by management to evaluate our overall performance as a supplement to our GAAP reported performance measures. As such, we believe that investors’ understanding of our performance is enhanced by disclosing this measure. We use Adjusted income, certain components of Adjusted income and Adjusted diluted EPS to present the results of our major operations––the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide––prior to considering certain income statement elements as follows:
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MeasureDefinitionRelevance of Metrics to Our Business Performance
Adjusted income
Net income attributable to Pfizer Inc. common shareholders(a) before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items
Provides investors useful information to:
evaluate the normal recurring operational activities, and their components, on a comparable year-over-year basis
assist in modeling expected future performance on a normalized basis
Provides investors insight into the way we manage our budgeting and forecasting, how we evaluate and manage our recurring operations and how we reward and compensate our senior management(b)
Adjusted cost of sales, Adjusted selling, informational and administrative expenses, Adjusted research and development expenses and Adjusted other (income)/deductions––net
Cost of sales, Selling, informational and administrative expenses, Research and development expenses and Other (income)/deductions––net (a), each before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items, which are components of the Adjusted income measure
Adjusted diluted EPS
EPS attributable to Pfizer Inc. common shareholders––diluted(a) before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items
(a)Most directly comparable GAAP measure.
(b)The short-term incentive plans for substantially all non-sales-force employees worldwide are funded from a pool based on our performance, measured in significant part versus three budgeted metrics, one of which is Adjusted diluted EPS (as defined for annual incentive compensation purposes), which is derived from Adjusted income and accounts for 40% of the bonus pool funding tied to financial performance. Additionally, the payout for performance share awards is determined in part by Adjusted net income, which is derived from Adjusted income. Beginning in the first quarter of 2022, we no longer exclude any expenses for acquired IPR&D from our non-GAAP Adjusted results but we continue to exclude certain of these expenses for our financial results for annual incentive compensation purposes. The bonus pool funding, which is largely based on financial performance, is adjusted by our R&D pipeline performance, as measured by four metrics, and performance against certain of our environmental, social and governance (ESG) metrics, and may be further modified by our Compensation Committee’s assessment of other factors.
Adjusted income and its components and Adjusted diluted EPS are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, are limited in their usefulness to investors. Because of their non-standardized definitions, they may not be comparable to the calculation of similar measures of other companies and are presented to permit investors to more fully understand how management assesses performance. A limitation of these measures is that they provide a view of our operations without including all events during a period, and do not provide a comparable view of our performance to peers. These measures are not, and should not be viewed as, substitutes for their most directly comparable GAAP measures of Net income attributable to Pfizer Inc. common shareholders, components of Net income attributable to Pfizer Inc. common shareholders and EPS attributable to Pfizer Inc. common shareholders—diluted, respectively.
We also recognize that, as internal measures of performance, these measures have limitations, and we do not restrict our performance-management process solely to these measures. We also use other tools designed to achieve the highest levels of performance. For example, our R&D organization has productivity targets, upon which its effectiveness is measured. In addition, total shareholder return, both on an absolute basis and relative to a publicly traded pharmaceutical index, plays a significant role in determining payouts under certain of our incentive compensation plans.
Beginning in the first quarter of 2022, our reconciliation of certain GAAP reported to non-GAAP adjusted information is updated to reflect the following, and prior-period information has been revised to conform to the current period presentation:

Adjusted Income and Adjusted Diluted EPS
Acquired IPR&D—Non-GAAP Adjusted financial measures include expenses for all acquired IPR&D costs incurred in connection with upfront and milestone payments on collaboration and in-license agreements, including premiums on equity securities, as well as asset acquisitions of acquired IPR&D. Previously, certain of these items were excluded from our non-GAAP adjusted results. Acquired IPR&D expenses that previously would have been excluded from non-GAAP Adjusted income but are now included in both GAAP Reported income and non-GAAP Adjusted income: (i) had no impact in the second quarter of 2022, (ii) were approximately $339 million pre-tax ($276 million, net of tax), or $0.05 per share, in the first six months of 2022 and (iii) were approximately $186 million for both pre-tax and net of tax, or $0.03 per share, in both the second quarter and first six months of 2021.
Amortization of Intangible Assets—We began excluding all amortization of intangibles from non-GAAP Adjusted income, compared to excluding only amortization of intangibles related to large mergers or acquisitions under the prior methodology, and presenting it as a separate reconciling line. Previously, the adjustment under the prior methodology was included as part of
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a reconciling line entitled “Purchase accounting adjustments” that we no longer separately present. The impact of this policy change resulted in benefits of $0.02 and $0.03 on Adjusted diluted EPS in the second quarter and first six months of 2022, respectively, and $0.03 and $0.04 in the second quarter and first six months of 2021, respectively.
Acquisition-Related Items—Adjusted income continues to exclude certain acquisition-related items, which are comprised of transaction, integration, restructuring charges and additional depreciation costs for business combinations because these costs are unique to each transaction and represent costs that were incurred to restructure and integrate businesses as a result of an acquisition. We have made no adjustments for resulting synergies. Beginning in the first quarter of 2022, acquisition-related items may now include purchase accounting impacts that previously would have been included as part of a reconciling line entitled “Purchase accounting adjustments” that we no longer separately present, such as: (i) the incremental charge to cost of sales from the sale of acquired inventory that was written up to fair value, (ii) depreciation related to the increase/decrease in fair value of acquired fixed assets, (iii) amortization related to the increase in fair value of acquired debt and (iv) the fair value changes for contingent consideration.
Discontinued Operations—Adjusted income continues to exclude the results of discontinued operations, as well as any related gains or losses on the disposal of such operations. We believe that this presentation is meaningful to investors because, while we review our therapeutic areas and product lines for strategic fit with our operations, we do not build or run our business with the intent to discontinue parts of our business. Restatements due to discontinued operations do not impact compensation or change the Adjusted income measure for the compensation in respect of the restated periods, but are presented for consistency across all periods.
Certain Significant Items—Adjusted income continues to exclude certain significant items representing substantive and/or unusual items that are evaluated individually on a quantitative and qualitative basis. Certain significant items may be highly variable and difficult to predict. Furthermore, in some cases it is reasonably possible that they could reoccur in future periods. For example, although major non-acquisition-related cost-reduction programs are specific to an event or goal with a defined term, we may have subsequent programs based on reorganizations of the business, cost productivity or in response to LOE or economic conditions. Legal charges to resolve litigation are also related to specific cases, which are facts and circumstances specific and, in some cases, may also be the result of litigation matters at acquired companies that were inestimable, not probable or unresolved at the date of acquisition. Gains and losses on equity securities, and pension and postretirement actuarial remeasurement gains and losses have a very high degree of inherent market volatility, which we do not control and cannot predict with any level of certainty and because we do not believe including these gains and losses assists investors in understanding our business or is reflective of our core operations and business. Unusual items represent items that are not part of our ongoing business; items that, either as a result of their nature or size, we would not expect to occur as part of our normal business on a regular basis; items that would be non-recurring; or items that relate to products we no longer sell.
See the Reconciliations of GAAP Reported to Non-GAAP Adjusted information—Certain Line Items below for a non-inclusive list of certain significant items and the Non-GAAP Financial Measure: Adjusted Income section within MD&A of our 2021 Form 10-K for additional information.

Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items
Three Months Ended July 3, 2022
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER COMMON SHARE DATA)
Cost of sales(a)
Selling, informational and administrative expenses(a)
Other (income)/deductions––net(a)
Net income attributable to Pfizer Inc. common shareholders(a)
Earnings per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP reported$8,648 $3,048 $772 $9,906 $1.73 
Amortization of intangible assets— — — 822 
Acquisition-related items(b)
(2)(13)82 
Discontinued operations(c)
— — — (34)
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(d)
(22)(134)— 272 
(Gains)/losses on equity securities— — (539)539 
Actuarial valuation and other pension and postretirement plan (gains)/losses— — (490)490 
Other(e)
(6)(13)(107)130 
Income tax provision—non-GAAP items(551)
Non-GAAP adjusted$8,625 $2,900 $(377)$11,656 $2.04 
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Six Months Ended July 3, 2022
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER COMMON SHARE DATA)
Cost of sales(a)
Selling, informational and administrative expenses(a)
Other (income)/deductions––net(a)
Net income attributable to Pfizer Inc.
common shareholders(a)
Earnings per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP reported$18,632 $5,642 $1,122 $17,769 $3.10 
Amortization of intangible assets— — — 1,657 
Acquisition-related items(b)
(3)(39)269 
Discontinued operations(c)
— — — (24)
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(d)
(42)(208)— 394 
(Gains)/losses on equity securities— — (1,237)1,237 
Actuarial valuation and other pension and postretirement plan (gains)/losses— — (418)418 
Other(e)
(17)(35)(211)273 
Income tax provision—Non-GAAP items(999)
Non-GAAP adjusted$18,582 $5,396 $(783)$20,993 $3.66 

Three Months Ended July 4, 2021
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER COMMON SHARE DATA)
Cost of sales(a)
Selling, informational and administrative expenses(a)
Other (income)/deductions––net(a)
Net income attributable to Pfizer Inc. common shareholders(a)
Earnings per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP reported$6,996 $2,923 $(1,343)$5,563 $0.98 
Amortization of intangible assets— (10)— 928 
Acquisition-related items(1)(37)34 
Discontinued operations(c)
— — — 346 
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(d)
(37)(96)— 129 
(Gains)/losses on equity securities— — 798 (798)
Actuarial valuation and other pension and postretirement plan (gains)/losses— — (6)
Other(e)
(16)(39)13 44 
Income tax provision—non-GAAP items(230)
Non-GAAP adjusted$6,949 $2,778 $(576)$6,023 $1.06 
Six Months Ended July 4, 2021
Data presented will not (in all cases) aggregate to totals.
(MILLIONS, EXCEPT PER COMMON SHARE DATA)
Cost of sales(a)
Selling, informational and administrative expenses(a)
Other (income)/deductions––net(a)
Net income attributable to Pfizer Inc. common shareholders(a)
Earnings per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP reported$11,153 $5,700 $(2,347)$10,440 $1.84 
Amortization of intangible assets— (19)(1)1,798 
Acquisition-related items11 (1)16 (27)
Discontinued operations(c)
— — — 337 
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(d)
(55)(160)— 234 
(Gains)/losses on equity securities— — 1,197 (1,197)
Actuarial valuation and other pension and postretirement plan (gains)/losses— — 33 (33)
Other(e)
(34)(99)(74)211 
Income tax provision—Non-GAAP items(390)
Non-GAAP adjusted$11,076 $5,421 $(1,177)$11,375 $2.01 
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(a)Items that reconcile GAAP Reported to non-GAAP Adjusted balances are shown pre-tax. Our effective tax rates for GAAP reported income from continuing operations were: 13.7% and 13.4% in the three and six months ended July 3, 2022, respectively, and 16.2% and 15.3% in the three and six months ended July 4, 2021, respectively. See Note 5. Our effective tax rates on non-GAAP adjusted income were: 15.4% and 15.1% in the three and six months ended July 3, 2022, respectively, and 17.1% and 16.3% in the three and six months ended July 4, 2021, respectively.
(b)Acquisition-related items in the three and six months ended July 3, 2022 primarily represent integration and other costs for the acquisition of Arena in March 2022. See Note 2A.
(c)Relates to the previously divested Meridian subsidiary and post-closing adjustments for other previously divested businesses. See Note 2B.
(d)Includes employee termination costs, asset impairments and other exit costs related to our cost-reduction and productivity initiatives not associated with acquisitions. See Note 3.
(e)For the second quarter of 2022, the total Other (income)/deductions––net adjustment of $107 million primarily includes charges of $55 million mostly representing our equity-method accounting pro rata share of costs of preparing for separation from GSK recorded by the GSK Consumer Healthcare JV, and charges of $19 million for certain legal matters. For the first six months of 2022, the total Other (income)/deductions––net adjustment of $211 million primarily includes charges for certain legal matters of $98 million and charges of $61 million mostly representing our equity-method accounting pro rata share of restructuring charges and costs of preparing for separation from GSK recorded by the GSK Consumer Healthcare JV. For the first six months of 2021, amounts in Selling, informational and administrative expenses of $99 million primarily include costs for consulting, legal, tax and advisory services associated with a non-recurring internal reorganization of legal entities. For the first six months of 2021, the total Other (income)/deductions––net adjustment of $74 million primarily includes charges of $81 million representing our equity-method accounting pro rata share of restructuring charges and costs of preparing for separation from GSK recorded by the GSK Consumer Healthcare JV. The second quarter and first six months of 2022 and 2021 include insignificant reconciling amounts for Research and development expenses.
ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Cash Flows from Continuing Operations
 Six Months Ended
(MILLIONS)July 3,
2022
July 4,
2021
Drivers of change
Cash provided by/(used in):
Operating activities from continuing operations$14,717 $15,828 
The change was driven primarily by (i) a decrease in the change in amounts due to BioNTech for the gross profit split for Comirnaty and a decrease in the change in deferred revenues (see Notes 8 and 13C), as well as (ii) the impact of timing of receipts and payments in the ordinary course of business, partially offset by (iii) higher net income adjusted for non-cash items, including an increase from non-cash unrealized losses on equity securities recognized in 2022, compared to unrealized gains recognized in 2021.
Investing activities from continuing operations$(10,746)$(9,880)
The change was driven mainly by $6.2 billion cash paid for the acquisition of Arena, net of cash acquired, a $3.0 billion increase in purchases of short-term investments with original maturities of greater than three months, a $2.6 billion increase in net purchases of short-term investments with original maturities of three months or less, and a $1.2 billion increase in purchases of long-term investments, partially offset by a $12.6 billion increase in redemptions of short-term investments with original maturities of greater than three months.
Financing activities from continuing operations$(4,058)$(5,364)
The change was driven mostly by $4.0 billion proceeds from short-term borrowings, largely reflecting the loan from the Consumer Healthcare JV (see Note 2C), and an $879 million net increase in proceeds from short-term borrowings with original maturities of three months or less, partially offset by $2.0 billion purchases of the Company’s common stock in 2022 and a $1.6 billion increase in repayments of long-term debt.
Cash Flows from Discontinued Operations
Cash flows from discontinued operations relate to previously divested businesses (see Note 2B).
ANALYSIS OF FINANCIAL CONDITION, LIQUIDITY, CAPITAL RESOURCES AND MARKET RISK
Due to our significant operating cash flows, which is a key strength of our liquidity and capital resources and our primary funding source, as well as our financial assets, access to capital markets, revolving credit agreements, and available lines of
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credit, we believe that we have, and will maintain, the ability to meet our liquidity needs to support ongoing operations, our capital allocation objectives, and our contractual and other obligations for the foreseeable future. For additional information, including information about off-balance sheet arrangements, see the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A in our 2021 Form 10-K. For information about the sources and uses of our funds, as well as our operating cash flows, see our condensed consolidated statements of cash flows, condensed consolidated balance sheets, condensed consolidated statements of equity, and the Analysis of the Condensed Consolidated Statements of Cash Flows within MD&A. For information on our money market funds, available-for sale-debt securities and long-term debt, see Note 7.
Debt Capacity––Lines of Credit
As of July 3, 2022, we had access to a $7 billion committed U.S. revolving credit facility expiring in 2026, which may be used for general corporate purposes including to support our commercial paper borrowings. In addition to the U.S. revolving credit facility, our lenders have provided us an additional $527 million in lines of credit, of which $495 million expire within one year. Essentially all lines of credit were unused as of July 3, 2022.
Capital Allocation Framework
Our capital allocation framework is primarily devised to facilitate (i) the achievement of medical breakthroughs through R&D investments and business development activities and (ii) returning capital to shareholders through dividends and share repurchases. See the Overview of Our Performance, Operating Environment, Strategy and Outlook section within MD&A of our 2021 Form 10-K. In April 2022, our BOD declared a dividend of $0.40 per share, paid on June 10, 2022, to shareholders of record at the close of business on May 13, 2022. In June 2022, our BOD declared a dividend of $0.40 per share, payable on September 6, 2022, to shareholders of record at the close of business on July 29, 2022.
In the first quarter of 2022, we purchased 39 million shares of our common stock at a cost of $2.0 billion under our publicly announced share purchase plan. We did not purchase shares in the second quarter of 2022. See Note 12 in our 2021 Form 10-K and Unregistered Sales of Equity Securities and Use of Proceeds in Part II, Item 2 for more information. At July 3, 2022, our remaining share-purchase authorization was approximately $3.3 billion.
In keeping with Pfizer’s transformation into a more focused, global leader in science-based innovative medicines and vaccines, we intend to exit our 32% ownership interest in Haleon in a disciplined manner, with the objective of maximizing value for our shareholders. See Note 2C.
Off-Balance Sheet Arrangements
For information about off-balance sheet arrangements, see the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A in our 2021 Form 10-K. For more information on guarantees and indemnifications, see Note 12B.
In March 2022, in connection with GSK’s previously announced planned demerger, the Consumer Healthcare JV issued notes of $8.75 billion, €2.35 billion and £700 million with various maturities. GSK guaranteed the notes and we agreed to indemnify GSK for 32% of any amount payable by GSK. In conjunction with the completion of GSK’s demerger transactions in July 2022, GSK’s guarantee and our related indemnification of GSK’s guarantee were terminated. See Note 2C.
Global Economic Conditions
Beginning in our second quarter of 2022, our operations in Turkey function in a hyperinflationary economy. The impact to Pfizer is not considered material. For more information about global economic conditions, see the Overview of Our Performance, Operating Environment, Strategy and Outlook—The Global Economic Environment section within this MD&A.
For additional information about our diverse sources of funds, global economic conditions, and information about credit ratings, market risk and LIBOR, see the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A in our 2021 Form 10-K.
NEW ACCOUNTING STANDARDS
Recently Adopted Accounting Standard
See Note 1B.
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Recently Issued Accounting Standards, Not Adopted as of July 3, 2022
Standard/DescriptionEffective DateEffect on the
Financial Statements
Reference rate reform provides temporary optional expedients and exceptions to the guidance for contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued after 2021 because of reference rate reform.
The new guidance provides the following optional expedients:
1.Simplify accounting analyses under current U.S. GAAP for contract modifications.
2.Simplify the assessment of hedge effectiveness and allow hedging relationships affected by reference rate reform to continue.
3.Allow a one-time election to sell or transfer debt securities classified as held to maturity that reference a rate affected by reference rate reform.
Elections can be adopted prospectively at any time through December 31, 2022.We are assessing the impact, but currently do not expect this new guidance to have a material impact on our consolidated financial statements.
In June 2022, the FASB issued final guidance to clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered when measuring fair value. Recognizing a contractual sale restriction as a separate unit of account is not permitted.
January 1, 2024, with early adoption permitted.
We are assessing the impact, but currently do not expect this new guidance to have a material impact on our consolidated financial statements.
FORWARD-LOOKING INFORMATION AND FACTORS THAT MAY AFFECT FUTURE RESULTS
This Form 10-Q contains forward-looking statements. We also provide forward-looking statements in other materials we release to the public, as well as public oral statements. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions.
We have tried, wherever possible, to identify such statements by using words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning or by using future dates.
We include forward-looking information in our discussion of the following, among other topics:
our anticipated operating and financial performance, reorganizations, business plans, strategy and prospects;
expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, clinical trial results and other developing data, revenue contribution, growth, performance, timing of exclusivity and potential benefits;
strategic reviews, capital allocation objectives, dividends and share repurchases;
plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities;
sales, expenses, interest rates, foreign exchange rates and the outcome of contingencies, such as legal proceedings;
expectations for impact of or changes to existing or new government regulations or laws;
our ability to anticipate and respond to macroeconomic, geopolitical, health and industry trends, pandemics, acts of war and other large-scale crises; and
manufacturing and product supply.
In particular, forward-looking information in this Form 10-Q includes statements relating to specific future actions and effects, including, among others, the expected benefits of the organizational changes to further transform our operations, including establishing a new commercial structure within Biopharma, our efforts to respond to COVID-19, including our plans and expectations regarding Comirnaty and Paxlovid, and any potential future vaccines or treatments; the forecasted revenue, demand, manufacturing and supply of Comirnaty and Paxlovid; our expectations regarding the impact of COVID-19 on our business; the expected impact of patent expiries and competition from generic manufacturers; the expected pricing pressures on our products and the anticipated impact to our business; the availability of raw materials for 2022; the expected charges and/or costs in connection with the spin-off of the Upjohn Business and its combination with Mylan; the benefits expected from our business development transactions; our anticipated liquidity position; the anticipated costs and savings from certain of our initiatives, including our Transforming to a More Focused Company program; and our planned capital spending.
Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. Actual outcomes may vary materially from past results and those anticipated, estimated, implied or projected. These forward-looking statements may be affected by underlying assumptions that may prove inaccurate or incomplete, or by known or unknown risks and uncertainties, including those described in this section and in the Item 1A. Risk Factors section in our 2021 Form 10-K.
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Therefore, you are cautioned not to unduly rely on forward-looking statements, which speak only as of the date of this Form 10-Q. We undertake no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. You are advised, however, to consult any further disclosures we make on related subjects.
Some of the factors that could cause actual results to differ are identified below, as well as those discussed in the Item 1A. Risk Factors section in our 2021 Form 10-K and within this MD&A. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. The occurrence of any of the risks identified below, in the Item 1A. Risk Factors section in our 2021 Form 10-K or within this MD&A, or other risks currently unknown, could have a material adverse effect on our business, financial condition or results, or we may be required to increase our accruals for contingencies. It is not possible to predict or identify all such factors. Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties:
Risks Related to Our Business, Industry and Operations, and Business Development
the outcome of R&D activities, including, the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and/or further analyses of existing pre-clinical or clinical data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; and whether and when additional data from our pipeline programs will be published in scientific journal publications, and if so, when and with what modifications and interpretations;
our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all; regulatory decisions impacting labeling, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; the impact of recommendations by technical or advisory committees; and the timing of pricing approvals and product launches;
claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the outcome of post-approval clinical trials, which could impact marketing approval, product labeling, and/or availability or commercial potential, including uncertainties regarding the commercial or other impact of the results of the Xeljanz ORAL Surveillance (A3921133) study or actions by regulatory authorities based on analysis of ORAL Surveillance or other data, including on other JAK inhibitors in our portfolio;
the success and impact of external business development activities, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which could result in increased leverage and/or a downgrade of our credit ratings; challenges integrating the businesses and operations; disruption to business and operations relationships; risks related to growing revenues for certain acquired products; significant transaction costs; and unknown liabilities;
competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates;
the ability to successfully market both new and existing products, including biosimilars;
difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions;
the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic), including the impact of vaccine mandates where applicable, on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
risks and uncertainties related to our efforts to develop and commercialize a vaccine to help prevent COVID-19 and an oral COVID-19 treatment, as well as challenges related to their manufacturing, supply and distribution;
risks related to our ability to achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments, including, among other things, whether and when additional supply or purchase agreements will be reached, the risk that demand for any products may be reduced or no longer exist and the possibility that COVID-19 will diminish in severity or prevalence or disappear entirely, which may lead to reduced revenues or excess inventory;
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trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;
interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates;
any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
the impact of the increased presence of counterfeit medicines or vaccines in the pharmaceutical supply chain;
any significant issues related to the outsourcing of certain operational and staff functions to third parties; and any significant issues related to our JVs and other third-party business arrangements;
uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation, and recent and possible future changes in global financial markets;
any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, civil unrest or military action;
the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, including our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines;
trade buying patterns;
the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives, and cost-reduction and productivity initiatives, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs or organizational disruption;
Risks Related to Government Regulation and Legal Proceedings
the impact of any U.S. healthcare reform or legislation or any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs or changes in the tax treatment of employer-sponsored health insurance that may be implemented;
U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access or restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive insurance markets;
legislation or regulatory action in markets outside of the U.S., including China, affecting pharmaceutical product pricing, intellectual property, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;
the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, as well as the impact of political unrest or civil unrest or military action, including the ongoing conflict between Russia and Ukraine and the continued economic consequences, unstable governments and legal systems and inter-governmental disputes;
legal defense costs, insurance expenses, settlement costs and contingencies, including those related to actual or alleged environmental contamination;
the risk and impact of an adverse decision or settlement and the adequacy of reserves related to legal proceedings;
the risk and impact of tax related litigation;
governmental laws and regulations affecting our operations, including, without limitation, changes in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S., including, among others, potential adoption of global minimum taxation requirements and potential changes to existing tax law by the current U.S. Presidential administration and Congress;
Risks Related to Intellectual Property, Technology and Security
any significant breakdown or interruption of our information technology systems and infrastructure (including cloud services);
any business disruption, theft of confidential or proprietary information, extortion or integrity compromise resulting from a cyber-attack or other malfeasance by third parties, including, but not limited to, nation states, employees, business partners or others;
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the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all; and
our ability to protect our patents and other intellectual property, such as against claims of invalidity that could result in LOE, including challenges faced by our collaboration or licensing partners to the validity of their patent rights, asserted and/or unasserted intellectual property claims and in response to any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection for or agreeing not to enforce or being restricted from enforcing intellectual property related to our products, including our vaccine to help prevent COVID-19 and our oral COVID-19 treatment.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Information required by this item is incorporated by reference from the discussion in the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section within MD&A of our 2021 Form 10-K.
ITEM 4. CONTROLS AND PROCEDURES
As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective in alerting them in a timely manner to material information required to be disclosed in our periodic reports filed with the SEC.
During our most recent fiscal quarter, there has not been any change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II.  OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

Certain legal proceedings in which we are involved are discussed in Note 12A.
ITEM 1A. RISK FACTORS
We refer to the Overview of Our Performance, Operating Environment, Strategy and Outlook—Our Operating Environment and —The Global Economic Environment sections and the Forward-Looking Information and Factors That May Affect Future Results section of the MD&A of this Form 10-Q and of our 2021 Form 10-K and to the Item 1A. Risk Factors section of our 2021 Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

The following summarizes purchases of our common stock during the second quarter of 2022:
Period
Total Number of
Shares Purchased(a)
Average Price
Paid per Share(a)
Total Number of Shares Purchased as Part of Publicly Announced Plan
Approximate Value of Shares That May Yet Be Purchased Under the Plan(b)
April 4 through May 1, 2022
22,946 $52.51 — $3,292,882,444 
May 2 through May 29, 2022
50,629 $49.77 — $3,292,882,444 
May 30 through July 3, 2022
77,399 $52.00 — $3,292,882,444 
Total150,974 $51.33 — 
(a)Represents (i) 149,013 shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive programs and (ii) the open market purchase by the trustee of 1,961 shares of common stock in connection with the reinvestment of dividends paid on common stock held in trust for employees who deferred receipt of performance share awards.
(b)See the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk—Capital Allocation Framework section within the MD&A of this Form 10-Q and Note 12 in our 2021 Form 10-K.
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ITEM 6. EXHIBITS
 -Certification by the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 -Certification by the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 -Certification by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 -Certification by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 Exhibit 101:  
EX-101.INSXBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
 EX-101.SCH
EX-101.CAL
EX-101.LAB
EX-101.PRE
EX-101.DEF
 Inline XBRL Taxonomy Extension Schema
Inline XBRL Taxonomy Extension Calculation Linkbase
Inline XBRL Taxonomy Extension Label Linkbase
Inline XBRL Taxonomy Extension Presentation Linkbase
Inline XBRL Taxonomy Extension Definition Document
Exhibit 104Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 Pfizer Inc.
 (Registrant)
  
  
Dated:August 10, 2022/s/ Jennifer B. Damico
 Jennifer B. Damico
Senior Vice President and Controller
(Principal Accounting Officer and
Duly Authorized Officer)
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